Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Chronic Skin Ulcer
• Intervention / Treatment: Biological: Platelet Rich Plasma Dressing; Other: Normal Saline Dressing

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 60000
      • Multan Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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
• Inability to comply with follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Platelet Rich Plasma Dressing; 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.	Biological: Platelet Rich Plasma Dressing; 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.; Other Names: Autologous platelet rich plasma wound dressing
Active Comparator: Group Normal Saline Dressing; 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.	Other: Normal Saline Dressing; 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.; Other Names: Saline moistened gauze dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Epithelialization of the Index Ulcer	Proportion of index ulcers achieving complete epithelialization (full wound closure) within the 6-week follow-up period, documented at scheduled visits.	Up to Week 6
Time to Complete Healing of the Index Ulcer	Time (in days) from randomization/baseline to first documented complete epithelialization among index ulcers that achieve closure during follow-up.	Up to Week 6
Change in Ulcer-Related Pain Score	Change in pain severity assessed using a Visual Analogue Scale from 0 to 10, recorded at baseline and at each follow-up visit, with change calculated from baseline to each subsequent visit and to Week 6.	Baseline and weekly assessments through Week 6

Collaborators and Investigators

• Sponsor: Multan Medical And Dental College
• Investigators: Principal Investigator: Saba Amin, Multan Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Actual): September 13, 2025
• Study Completion (Actual): September 13, 2025

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Wound Healing; Platelet Rich Plasma; Normal Saline Dressing; Ulcer Area Reduction; Complete Epithelialization
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Skin and Connective Tissue Diseases; Diabetic Foot
• Other Study ID Numbers: MMDC1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No