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Completed

NCT Number: NCT07420868

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Multan Medical and Dental College

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Autologous platelet rich plasma wound 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.

Other names: Saline moistened gauze dressing

Primary outcomes

  1. Percentage Reduction in Index Ulcer Area

    Time frame: Baseline to Week 6

    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.

Secondary outcomes

  1. Complete Epithelialization of the Index Ulcer

    Time frame: Up to Week 6

    Proportion of index ulcers achieving complete epithelialization (full wound closure) within the 6-week follow-up period, documented at scheduled visits.

  2. Time to Complete Healing of the Index Ulcer

    Time frame: Up to Week 6

    Time (in days) from randomization/baseline to first documented complete epithelialization among index ulcers that achieve closure during follow-up.

  3. Change in Ulcer-Related Pain Score

    Time frame: Baseline and weekly assessments through Week 6

    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.

Sponsors and collaborators

Lead sponsor

Multan Medical And Dental College

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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