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

February 12, 2026 updated by: Saba Amin, Multan Medical And Dental College
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to Week 6
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.
Up to Week 6
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.
Baseline and weekly assessments through Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Multan Medical And Dental College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Saba Amin, Multan Medical and Dental College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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