Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care

April 30, 2026 updated by: Daryoush Hamidi Alamdari, PhD, Mashhad University of Medical Sciences

Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care

The aim of this study is to eliminate the malodorous of chronic wound and increase the chance of the healing of recalcitrant wounds by using the repairing gel (supraz gel) which has the approved components in wound healing and platelet-rich plasma-fibrin glue.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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 current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) along with the use of the repairing gel which has the approved components on wound healing in patients with chronic wounds and to eliminate the malodorous of chronic wound. This randomized controlled trial is performed on patients with chronic wounds. Patients will be treated with repairing gel (supraz gel) plus PRP-FG dressing (intervention group) or only Supraz gel (intervention group) or only PRP-FG dressing (intervention group) every 48 hours for 8 weeks versus standard of care of treatment (control group: irrigation of wound by normal saline 0.9%).

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.
40

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.
  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Iran
    • Razavi Khorasan Province
      • Mashhad, Razavi Khorasan Province, Iran, 99191-91778
        • Mashhad University of Medical Sciences

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing
  • Having a body mass index of 18-35
  • Sign the informed consent by the patient

Exclusion Criteria:

  • Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure
  • Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

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.
Experimental: Platelet-Rich Plasma-Fibrin Glue
The first intervention group (group A) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing platelet-rich plasma-fibrin glue intervention for 8 weeks.
Drug: Platelet-Rich Plasma-Fibrin Glue
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Other Names:
  • PRP-FG
Experimental: Repairing Gel
The second intervention group (group B) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing repairing gel intervention for 8 weeks. The components of repairing gel are vitamin A - vitamin C - vitamin B3 - glycine amino acid. - ethanol - collagen - citric acid - glycerin - malic acid - urea - carboxymethyl cellulose - Sodium alginate - Benzoic acid - Allantoin - Bromelain - Methylene blue - Violet dimethyl sulfoxide . The formulation is patented. (PCT, IR108458)
Drug: Repairing Gel
The second intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel for 8 weeks.
Other Names:
  • Supraz Gel
Experimental: Platelet-Rich Plasma-Fibrin Glue and Repairing Gel
The third intervention group (group C) includes 10 patients with chronic wounds who, despite classic wound irrigation treatment, will be undergoing the repairing gel with approved wound healing components and platelet-fibrin glue for 8 weeks.
Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
The third intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone the repairing gel with approved wound healing components in the form of gel and PRP-FG for 8 weeks.
Other Names:
  • Supraz Gel and PRP-FG
Experimental: Classical wound irrigation (control)
For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks.
Other: Classical wound irrigation (control)
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
Other Names:
  • Control

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
Wound Odor Change
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Change from Baseline Wound Odor intensity at 2 months will be assessed by the nurse using a Visual Analog Scale (VAS) from 0 to 100 (perceived odor).
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Wound Size Change
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Change from Baseline Wound Size (length and width) at 2 months will be assessed in digital images taken of the wound.
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Visual Analog Scale changes for pain assessment
Time Frame: Every 48 hours for 8 weeks
Pain will be evaluated by the visual analog scale system (VAS) which assesses changes in pain via a continuous measurement instrument. The score is determined by measuring the distance (mm) between the no-pain anchor to the point that the patient marks, providing a range of scores from 0 - 10. A higher score indicates greater pain intensity.
Every 48 hours for 8 weeks
Duration of recovery
Time Frame: 8 weeks
The duration of recovery, which is the number of days it will be taken for the wound to heal.
8 weeks
Change in the systemic inflammatory marker C-reactive protein (CRP)
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
C-reactive protein (CRP)
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
erythrocyte sedimentation rate (ESR)
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Change in systemic inflammatory marker Interleukin 6 (IL-6)
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Interleukin 6 (IL-6)
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Number of participants with infection
Time Frame: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
A swab culture: Identify a small area (1 cm) of clean viable tissue and rotate the swab on it for 5 seconds while applying enough pressure to produce exudate and culture it to detect bacteria.
At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Results of the SF36 questionnaire at inclusion
Time Frame: Day 0
The SF-36 questionnaire is a quality-of-life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Day 0
Results of the SF36 questionnaire at Month 2
Time Frame: Month 2
The SF-36 questionnaire is a quality-of-life questionnaire that includes 36 questions divided into 8 different categories (physical functioning, limitations due to physical condition, physical pain, perceived health, vitality, social functioning or well-being, limitations due to mental condition, mental health). These 8 dimensions are used to calculate two scores on the quality of life of individuals: the physical composite score and the mental composite score. The higher the score, the greater the capacity. It is self-administered and takes less than 10 minutes. Higher scores indicate better quality of life. The French version has been validated and has satisfactory psychometric properties. Score from 0 to 100.
Month 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage rate of re-epithelialization
Time Frame: Participants will be followed for the duration of 8 weeks
Pictures taken of the wound site every other day will be analyzed using imaging software for the size of the wound. The percentage rate will be calculated from this.
Participants will be followed for the duration of 8 weeks

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.
Mashhad University of Medical Sciences

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.
Aristotle University Of Thessaloniki

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daryoush Hamidi Alamdari, Ph.D, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
  • Principal Investigator: Daryoush Hamidi Alamdari, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

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 (Actual)

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.
August 20, 2023

Primary Completion (Actual)

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.
January 20, 2024

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.
March 20, 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).
June 30, 2023

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.
August 1, 2023

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.
August 9, 2023

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.
May 6, 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.
April 30, 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.
March 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.
  • IR.MUMS.REC.1402.089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data related to the project after the unidentifiable people will be shared.

IPD Sharing Time Frame

Access to data is allowed 6 months after the publication of results.

IPD Sharing Access Criteria

The investigator's data will be available to university staff and academic institutions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings