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

NCT07420868 | Completed

• 1 other identifier: MMDC1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Skin Ulcer; Diabetic Foot Ulcer

Keywords

Platelet Rich Plasma; Normal Saline Dressing; Wound Healing; Ulcer Area Reduction; Complete Epithelialization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group Platelet Rich Plasma Dressing

EXPERIMENTAL

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

Group Normal Saline Dressing

ACTIVE COMPARATOR

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

Interventions

Platelet Rich Plasma Dressing BIOLOGICAL

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.

Also known as: Autologous platelet rich plasma wound dressing

Group Platelet Rich Plasma Dressing

Normal Saline Dressing OTHER

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.

Also known as: Saline moistened gauze dressing

Group Normal Saline Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Multan Medical And Dental College: lead

Study Sites (1)

Multan Medical and Dental College

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Saba Amin

  Multan Medical And Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: March 14, 2025
• Primary Completion: September 13, 2025
• Study Completion: September 13, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

PA (1)