A Phase 2/3 interventional study of Platelet-Rich Plasma-Fibrin Glue and Repairing Gel in Wounds and Injuries, sponsored by Mashhad University of Medical Sciences. Active, not recruiting at 1 site in Iran. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Mashhad University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
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%).
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Mashhad University of Medical Sciences is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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
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)
The first intervention group includes 10 patients with chronic wounds who, despite common treatment, will be undergone PRP-FG intervention for 8 weeks.
Also known as: PRP-FG
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.
Also known as: Supraz Gel
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.
Also known as: Supraz Gel and PRP-FG
For 10 patients with chronic wounds, only the classical wound irrigation by normal saline will be continued for 8 weeks.
Also known as: Control
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Change in the systemic inflammatory marker C-reactive protein (CRP)
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)
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
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)
Change in systemic inflammatory marker Interleukin 6 (IL-6)
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 2
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.
Time frame: Participants will be followed for the duration of 8 weeks
Plan to share: Yes — All data related to the project after the unidentifiable people will be shared.
Supporting information: Study protocol, Informed consent form
Time frame: Access to data is allowed 6 months after the publication of results.
Access criteria: The investigator's data will be available to university staff and academic institutions.
No publications or documents are linked to this record.
Ran from Aug 2023 to primary completion in Jan 2024, 5 months.
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Mashhad University of Medical Sciences