The WARM Study is a Pilot Study That Aims to Investigate the Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg. (WARM)

June 5, 2026 updated by: University Hospital Augsburg

Impact of Environmental Factors on Acute and Chronic Wounds, Mental Illness, and Social Factors Among People Experiencing Housing Emergencies in Augsburg

Providing healthcare to homeless people is a key and challenging task, both for society as a whole and for medical and psychosocial professionals. It must be noted that the standard healthcare system is hardly used, or can only be used to an insufficient extent, by homeless people, and therefore does not comprehensively reach this group. One low-threshold and acceptance-oriented service outside the standard care system is the Johanniter-Hilfsmobil, which was established on June 3, 2024, as an innovative approach to healthcare for homeless people in Augsburg and will be scientifically examined in the following study.

The aim is to compare acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter-Hilfsmobil with those of patients who attend the outpatient wound clinic at the Clinic for Vascular Surgery at Augsburg University Hospital.

In addition, a saliva test will be carried out to estimate the amount and type of substance consumed, and a survey will be conducted among drug-dependent test subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.

Another focus of research is the quantitative and qualitative analysis of the psychosocial living situation and environmental influences on users of the Johanniter-Hilfsmobil.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary endpoint is to identify positive and negative influences of environmental factors on the development, progression, and healing of somatic and psychiatric illnesses in homeless people in Augsburg. The answers to the resulting research questions listed below should contribute to the development of a sustainable diagnosis and therapy system by the Johanniter-Hilfsmobil for people in housing emergencies without access to the regular health care system in Augsburg, optimizing addiction treatment for homeless people in the region, and establishing a prevention program for people experiencing housing emergencies in Augsburg, thereby positively influencing the environmental factors described. The long-term plan is to set up a wound and vascular consultation service for people experiencing housing emergencies to improve medical treatment and reintegration into the regular healthcare system.

A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital. The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonization by taking swabs from the wound bed and performing corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed, and causal therapeutic measures taken to date, as well as the number and regularity of check-ups performed, will be recorded. Furthermore, the influence of environmental factors (including temperature, light, radiation), comorbidities, and nutritional status on wound healing and the effects of dressing sets provided as part of the study on the healing process of the wounds will be analyzed. Data collection will be carried out on an outpatient basis during treatment in the Johanniter-Hilfsmobil. In addition, the existing cardiovascular risk factors will be assessed and a vascular step-by-step diagnosis will be performed, including pulse status assessment and, in the event of pathological findings, non-invasive vascular imaging using ankle-brachial index determination and color-coded duplex sonography (FKDS).

In addition, semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted among drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy, and Psychosomatics at Augsburg District Hospital.

Another focus of research is the quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardized questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, garbage/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system. The questionnaire integrates the following measurement instruments/scales, among others: "Life Situation Index for Homeless People", "RTLS - Rasch-Type Loneliness Scale".

However, since this is a very specific target group that has been largely neglected in scientific analysis, the questionnaire also requires some self-formulated items that are appropriate for the research project.

In a final step, a qualitative analysis will be conducted through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18
  • Existing capacity to consent to participation in the study, which will be verified and documented by the study physicians
  • Inclusion of patients who present for wound treatment at the Johanniter-Hilfsmobil, the wound consultation hour of the Clinic for Vascular Surgery at Augsburg University Hospital and/or the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital
  • Written consent to participate in the study has been obtained from the test subject.

Exclusion Criteria:

  • Minderjährigkeit
  • Fehlende schriftliche Einwilligung zur Studienteilnahme
  • Instabiler somatischer Zustand der Betroffenen
  • Akute Selbst- und Fremdgefährdung

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Saliva testing
Semi-quantitative and quantitative saliva tests and a questionnaire survey are conducted on drug-dependent subjects who present themselves either via the Johanniter-Hilfsmobil or via the substitution outpatient clinic of the Clinic for Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital.
Experimental: Wound Care Treatment

A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those in patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital.

The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. Furthermore, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded.
Other: Wound care at the University Hospital and in the Johanniter mobile wound care unit

A comparison will be made between acute and chronic wounds in people experiencing housing emergencies who are treated by the Johanniter mobile emergency service and those of patients who attend outpatient wound consultations at the Clinic for Vascular Surgery at Augsburg University Hospital.

The following data will be collected: wound area and volume, as well as qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and performing the corresponding laboratory chemical analysis. In addition, the cause or origin of the wounds, the type of diagnostics performed and causal therapeutic measures taken to date, as well as the number and regularity of the checks carried out will be recorded. The influence of environmental factors, comorbidities and nutritional status on wound healing and the effects of the dressing sets provided as part of the study on the healing process of the wounds will also be analysed.
No Intervention: Questionnaire on psychosocial life situation
The quantitative analysis of the psychosocial living situation due to exceptional environmental influences based on subjective and/or objective recording of the following constructs and categories among users of the Johanniter-Hilfsmobil using a standardised questionnaire: Life situation index (material situation, gainful employment, housing, health, safety, participation/social networks), environmental influences and weather conditions (heat/cold, precipitation, wind, air quality, noise, rubbish/unhygienic conditions), opportunities for a healthy lifestyle (nutrition, access to drinking water, sleep, regeneration), use of public space and urban infrastructure (mobility, participation, defensive architecture), experiences of loneliness, and experiences with and access to the medical and psychosocial care system.
No Intervention: Guided interview on psychosocial circumstances
A qualitative analysis will be conducted through guided interviews with up to 15 users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings on the psychosocial living situation and the environmental influences to which they are exposed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Identification of the positive and negative effects of environmental factors on the onset, progression and recovery from of chronic wounds among homeless people who use the Johanniter-Hilfsmobil in Augsburg
Time Frame: 0-365 days

To answer the research question, the following data will be collected from study participants via a questionnaire and clinical examination:

  • Wound area and volume (wound length in cm, wound width in cm, wound area in cm², wound depth in cm),
  • Qualitative and quantitative analysis of bacterial and/or fungal colonisation by taking swabs from the wound bed and conducting the corresponding laboratory tests (incubation on culture media)
  • Determination of the cause of the wounds (for example caused by cold or heat) through medical history and clinical examination
  • Assessment of nutritional status by calculating the body mass index (kg/m²)
  • Assessment of existing cardiovascular risk factors (for example hypertension, or tobacco use)
  • Vascular assessment, including examination of the pulse status in the lower limbs and if pathological findings are observed non-invasive vascular imaging is performed using the ankle-brachial index and colour-coded duplex sonography
0-365 days
Identification of a discrepancy between the substance subjectively perceived to have been consumed and the substance objectively detectable in drug-dependent homeless individuals
Time Frame: 0 - 365 days

In order to identify any discrepancies between the substance the study participant subjectively believes they have consumed and the substance objectively detected, saliva tests are carried out which are chemically analysed in the laboratory for the presence of the following groups of substances:

  • Amphetamines and derivatives
  • Benzodiazepines
  • Cocaine and cocaine metabolites
  • Cannabinoids
  • Other substances (including ketamine)
  • Synthetic cannabinoids

To determine the substance the participant subjectively perceives to have consumed, a questionnaire is administered to assess the participant's current substance use.
0 - 365 days
Assessing the impact of environmental factors on the psychosocial circumstances of users of the Johanniter mobile support service.
Time Frame: 0 - 365 days

Quantitative analysis of the psychosocial circumstances of users of the Johanniter-Hilfsmobil due to exceptional environmental influences, using a standardised questionnaire.

The following metrics are to be collected:

  • Life circumstances index (material situation, gainful employment, housing, health, safety, participation/social networks)
  • Environmental factors and weather conditions (heat/cold, precipitation, wind, air quality, noise, litter/unhygienic conditions)
  • Opportunities for a healthy lifestyle (diet, access to drinking water, sleep, recovery)
  • Use of public spaces and urban infrastructure (mobility, participation, defensive architecture)
  • Experiences of loneliness
  • Experiences with and access to the medical and psychosocial care system.
0 - 365 days
Survey of the psychosocial circumstances and the environmental factors of which they are exposed of homeless people in Augsburg using the Johanniter-Hilfsmobil
Time Frame: 0-365 days

As a final step, a qualitative analysis will be carried out through guided interviews with users of the Johanniter-Hilfsmobil to gain a deeper understanding of the quantitative findings regarding their psychosocial circumstances and the environmental factors to which they are exposed.

The following categories will be covered in the personal interview with the homeless persons:

  • General living situation
  • Public spaces and urban infrastructure
  • Environmental influences and weather conditions
  • Health
  • Social support
  • Medical, psychological and social care
0-365 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in consumption patterns in relation to the season
Time Frame: 0 - 365 days
In order to identify any seasonal variations in consumption patterns, a statistical analysis is carried out based on the results of saliva samples taken from drug-dependent individuals who present themselves either via the Johanniter-Hilfsmobil or via the substitution clinic at the Department of Psychiatry, Psychotherapy and Psychosomatics at Augsburg District Hospital.
0 - 365 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Augsburg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Applied Science Augsburg, Germany
Department of Psychiatry, Psychotherapie and Psychosomatics, Medical Faculty, University of Augsburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Gerull S. Systematische Lebenslagenuntersuchung wohnungsloser Menschen 2018 [Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/246 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-2465. 2. Gerull S. Wohnungslos in unsicheren Zeiten 2022 [1-57]. Available from: https://opus4.kobv.de/opus4-ash/frontdoor/index/index/docId/496 https://nbn-resolving.org/urn:nbn:de:kobv:b1533-opus-4961. 3. Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness:Confirmatory Tests on Survey Data. Research on Aging. 2006;28(5):582-98.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-0578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As people in housing emergencies are a particularly vulnerable group requiring protection, in accordance with the positive ethical opinion of the Ethics Committee at the Medical Faculty of Ludwig Maximilian University Munich, there are no plans to make the pseudonymised data available to other study centres for further processing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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