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)

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: Not yet recruiting
• Conditions: Homelessness; Psychiatric Disorders; Homeless Persons; Drug Abuse/Dependence; Wound and Injuries; Chronic Wound Care; Environmental Factors; Environmental Health
• Intervention / Treatment: Other: Wound care at the University Hospital and in the Johanniter mobile wound care unit

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: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • University Hospital Augsburg
      • Contact: Tobias D Warm, Dr. med.; Phone Number: +498214002655; Email: tobias.warm@uk-augsburg.de
      • Contact: Alexander Hyhlik-Dürr, Prof. Dr. med.; Phone Number: +498214002655; Email: alexander.hyhlik-duerr@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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	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.	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	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

Outcome Measure	Measure Description	Time Frame
Difference in consumption patterns in relation to the season	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

• Sponsor: University Hospital Augsburg
• Collaborators: University of Applied Science Augsburg, Germany; Department of Psychiatry, Psychotherapie and Psychosomatics, Medical Faculty, University of Augsburg, Germany

Publications and helpful links

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

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: wound care; psychiatric disorders; environmental health; homeless persons; wound and injuries; drug abuse/dependence
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Wounds and Injuries; Mental Disorders
• Other Study ID 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