Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Ve… (NCT05983302) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Elimination of Odor and Treatment of Malodorous Recalcitrant Wounds by Using Supraz and PRP-FG Versus Standard of Care
Iran40 participantsStarted 2023-08-20
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wound Odor Change
Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
2
Wound Size Change
Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
3
Visual Analog Scale changes for pain assessment
Timeframe: Every 48 hours for 8 weeks
4
Duration of recovery
Timeframe: 8 weeks
5
Change in the systemic inflammatory marker C-reactive protein (CRP)
Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
6
Change in systemic inflammatory marker erythrocyte sedimentation rate (ESR)
Timeframe: At the beginning of the study (0 day) and at the end of the eighth week of the intervention (8 weeks)
7
Change in systemic inflammatory marker Interleukin 6 (IL-6)