Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing… (NCT07420868) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
Pakistan100 participantsStarted 2025-03-14
Plain-language summary
This randomized controlled trial will compare platelet rich plasma dressing with normal saline dressing for the treatment of chronic non healing cutaneous ulcers, including diabetic foot ulcers, venous leg ulcers, pressure ulcers, and other suitable chronic ulcers of at least six weeks duration. A total of 100 adults will be recruited from the Department of Dermatology, Multan Medical and Dental College, and allocated in a 1:1 ratio to receive either autologous platelet rich plasma dressing or normal saline dressing for six weeks, with both groups receiving the same standardized wound care package including debridement when indicated, infection control, moisture balance, and etiology specific supportive measures such as offloading or compression. The hypothesis is that platelet rich plasma dressing will lead to greater wound healing by supplying concentrated platelets and naturally occurring growth factors that support granulation tissue formation and re epithelialization. The primary outcome is the percentage reduction in ulcer area from baseline to the end of follow up, measured using standardized planimetry. Secondary outcomes include the proportion of ulcers achieving complete epithelialization within the follow up period, time to complete healing among ulcers that close, and change in pain scores during treatment.
Who can participate
Age range
18 Years
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:
* Age 18 years or above
* Either gender
* Chronic non healing cutaneous ulcer of at least 6 weeks duration
* Ulcer etiology eligible for conservative dressing-based management, including
* Diabetic foot, Venous leg and Pressure ulcer
* Other chronic ulcers considered suitable by the treating dermatologist
* Measurable index ulcer surface area suitable for standardized photography and planimetric assessment
* Clinically acceptable wound bed after initial wound bed preparation
* No requirement for urgent surgical reconstruction at enrolment
* Ability to attend twice weekly dressing visits for 6 weeks
* Provision of written informed consent
Exclusion Criteria:
* Suspected or proven malignant ulceration
* Vasculitic or inflammatory ulcers requiring systemic immunosuppression
* Pyoderma gangrenosum
* Critical limb ischemia or severe perfusion compromise on clinical assessment, with vascular screening where feasible
* Requirement for urgent revascularization
* Active osteomyelitis requiring bony debridement
* Exposed bone with high suspicion of osteomyelitis
* Rapidly spreading soft tissue infection
* Systemic sepsis
* Hematological abnormalities making venesection or platelet rich plasma preparation unsafe, including
* Clinically relevant platelet dysfunction
* Known bleeding diathesis
* Therapeutic anticoagulation where temporary interruption is not clinically appropriate
* Pregnancy or lactation
* Participation in another interventional wound trial
* Inabi…
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.