Wounds and InjuriesPhase 2/3NCT05983302
Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
A Phase 2/3 study testing Platelet-Rich Plasma-Fibrin Glue, Repairing Gel and Repairing Gel and Platelet-Rich Plasma-Fibrin Glue in people with Wounds and Injuries, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Platelet-Rich Plasma-Fibrin Glue, Repairing Gel and Repairing Gel and Platelet-Rich Plasma-Fibrin Glue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 20 Aug 2023to 20 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 99191-91778
About this study
Official title: 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.
Read the 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%).
- Conditions
- Wounds and Injuries
- Being tested
- Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Repairing Gel and Platelet-Rich Plasma-Fibrin Glue, Classical wound irrigation (control)
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Chronic Wounds, Malodorous, Recalcitrant
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma-Fibrin GlueDrug
Also called PRP-FG
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Repairing GelDrug
Also called Supraz 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.
Repairing Gel and Platelet-Rich Plasma-Fibrin GlueDrug
Also called Supraz Gel and PRP-FG
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.
Classical wound irrigation (control)Other
Also called Control
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Plasma-Fibrin Glue | Experimental | 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. Receives: Drug: Platelet-Rich Plasma-Fibrin Glue |
| Repairing Gel | Experimental | 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) Receives: Drug: Repairing Gel |
| Platelet-Rich Plasma-Fibrin Glue and Repairing Gel | Experimental | 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. Receives: Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin Glue |
| Classical wound irrigation (control) | Experimental | For 10 patients with chronic wounds, only classical wound irrigation by normal saline (0.9%) will be continued for 8 weeks. Receives: Other: Classical wound irrigation (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Odor Change
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).
Measured: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
Wound Size Change
Change from Baseline Wound Size (length and width) at 2 months will be assessed in digital images taken of the wound.
Measured: 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
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.
Measured: Every 48 hours for 8 weeks
Duration of recovery
The duration of recovery, which is the number of days it will be taken for the wound to heal.
Measured: 8 weeks
Change in the systemic inflammatory marker C-reactive protein (CRP)
C-reactive protein (CRP)
Measured: 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)
erythrocyte sedimentation rate (ESR)
Measured: 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)
Interleukin 6 (IL-6)
Measured: 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
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.
Measured: 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
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.
Measured: Day 0
Results of the SF36 questionnaire at 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.
Measured: Month 2
Secondary outcomes (1)
Percentage rate of re-epithelialization
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.
Measured: Participants will be followed for the duration of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start20 Aug 2023
- Primary completion20 Jan 2024
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryoush Hamidi Alamdari, PhD, Mashhad University of Medical Sciences
- Investigators
- Daryoush Hamidi Alamdari, Ph.D, Principal investigator, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.Daryoush Hamidi Alamdari, Principal investigator, Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983302
- Sponsor's protocol ID
- IR.MUMS.REC.1402.089
- Status last verified
- Mar 2026
- First submitted
- 30 Jun 2023
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data related to the project after the unidentifiable people will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care
- ClinicalTrials.gov ID
- NCT05983302
- Acronym / sponsor ID
- IR.MUMS.REC.1402.089
- Conditions
- Wounds and Injuries
- Keywords
- Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Chronic Wounds, Malodorous, Recalcitrant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Jan 2024 (actual)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Plasma-Fibrin Glue | Experimental | Drug: Platelet-Rich Plasma-Fibrin GlueThe 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. |
| Repairing Gel | Experimental | Drug: Repairing GelThe 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) |
| Platelet-Rich Plasma-Fibrin Glue and Repairing Gel | Experimental | Drug: Repairing Gel and Platelet-Rich Plasma-Fibrin GlueThe 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. |
| Classical wound irrigation (control) | Experimental | Other: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich Plasma-Fibrin GlueAlso: PRP-FGThe first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks. | Drug | Platelet-Rich Plasma-Fibrin Glue |
| Repairing GelAlso: Supraz GelThe 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. | Drug | Repairing Gel |
| Repairing Gel and Platelet-Rich Plasma-Fibrin GlueAlso: Supraz Gel and PRP-FGThe 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. | Drug | Platelet-Rich Plasma-Fibrin Glue and Repairing Gel |
| Classical wound irrigation (control)Also: ControlFor 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks. | Other | Classical wound irrigation (control) |
Primary outcome
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).
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.
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.
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.
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)
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)
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)
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.
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.
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.
1 secondary outcome
Percentage rate of re-epithelialization
Time frame: Participants will be followed for the duration of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. All data related to the project after the unidentifiable people will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daryoush Hamidi Alamdari, Ph.D principal investigator
Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Daryoush Hamidi Alamdari principal investigator
Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platelet-Rich Plasma-Fibrin Glue, Repairing Gel and Repairing Gel and Platelet-Rich Plasma-Fibrin Glue in people with Wounds and Injuries, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.