Sponsor study identifier
interventional
100
1 country
1
Study Start
March 14, 2025
Actual (reported)Primary Completion
September 13, 2025
Actual (reported)Study Completion
September 13, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 13, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 14, 2025
Actual (reported)September 13, 2025
Actual (reported)September 13, 2025
Actual (reported)February 12, 2026
Actual (reported)February 19, 2026
Actual (reported)Percentage Reduction in Index Ulcer Area
Percentage change in ulcer surface area from baseline to Week 6, measured by standardized planimetry using either transparent grid tracing or calibrated digital photography with software-based area calculation. The same measurement method will be applied consistently for each participant.
Baseline to Week 6
Complete Epithelialization of the Index Ulcer
Up to Week 6
Time to Complete Healing of the Index Ulcer
Up to Week 6
Change in Ulcer-Related Pain Score
Baseline and weekly assessments through Week 6
Received autologous platelet rich plasma applied topically to the ulcer bed after standard wound cleansing with normal saline and debridement when indicated, followed by a non adherent secondary dressing, absorbent padding, and fixation bandage. Supportive measures such as offloading for neuropathic or pressure related ulcers and compression therapy for venous leg ulcers were provided as indicated, using the same standardized care package as the comparator arm.
Received ulcer cleansing with normal saline followed by sterile gauze moistened with normal saline, then the same standardized secondary dressing and fixation method used in the experimental arm. Supportive measures including debridement when indicated, infection management, moisture balance, offloading, and compression therapy were provided according to ulcer etiology using the same standardized care package as the experimental arm.
Autologous platelet rich plasma prepared under aseptic conditions using a standardized double centrifugation method and applied evenly over the entire wound bed at scheduled dressing visits for 6 weeks, with interim secondary dressing changes as clinically indicated based on exudate, using the same secondary dressing type across participants.
Multan Medical and Dental College
Multan, Punjab Province, 60000, Pakistan
Saba Amin
Multan Medical And Dental College
100 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2026
First Posted
February 19, 2026
Study Start
March 14, 2025
Actual (reported)Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy
Normal saline cleansing and sterile gauze dressing moistened with normal saline applied at scheduled dressing visits for 6 weeks, with additional dressing changes permitted if clinically indicated due to exudate soakage, and all changes documented.
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Primary Completion
September 13, 2025
Actual (reported)Study Completion
September 13, 2025
Actual (reported)Last Updated
February 19, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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