Chronic Skin UlcerNCT07420868
Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
A study testing Platelet Rich Plasma Dressing and Normal Saline Dressing in people with Chronic Skin Ulcer and Diabetic Foot Ulcer, run by Multan Medical And Dental College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Skin Ulcer, Diabetic Foot Ulcer
- What is being tested?
- Platelet Rich Plasma Dressing and Normal Saline Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Mar 2025to 13 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Multan Medical and Dental College
Multan, Punjab Province, 60000
About this study
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
- Being tested
- Platelet Rich Plasma Dressing, Normal Saline Dressing
- Keywords
- Platelet Rich Plasma, Normal Saline Dressing, Wound Healing, Ulcer Area Reduction, Complete Epithelialization
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma DressingBiological
Also called Autologous platelet rich plasma wound 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.
Normal Saline DressingOther
Also called Saline moistened gauze 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal Saline Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 6
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and weekly assessments through Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start14 Mar 2025
- Primary completion13 Sep 2025
- Study completion13 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Skin UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multan Medical And Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saba Amin, Multan Medical And Dental College
- Investigators
- Saba Amin, Principal investigator, Multan Medical And Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420868
- Sponsor's protocol ID
- MMDC1
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Platelet-Rich Plasma Dressing Versus Normal Saline Dressing for Chronic Non-Healing Ulcers
- ClinicalTrials.gov ID
- NCT07420868
- Acronym / sponsor ID
- MMDC1
- Conditions
- Chronic Skin Ulcer, Diabetic Foot Ulcer
- Keywords
- Platelet Rich Plasma, Normal Saline Dressing, Wound Healing, Ulcer Area Reduction, Complete Epithelialization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Multan Medical And Dental CollegeUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 13 Sep 2025 (actual)
- Study completion
- 13 Sep 2025 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Platelet Rich Plasma Dressing | Experimental | Biological: Platelet Rich Plasma DressingReceived 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. |
| Group Normal Saline Dressing | Active comparator | Other: Normal Saline DressingReceived 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma DressingAlso: Autologous platelet rich plasma wound dressingAutologous 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. | Biological | Group Platelet Rich Plasma Dressing |
| Normal Saline DressingAlso: Saline moistened gauze dressingNormal 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 | Group Normal Saline Dressing |
Primary outcome
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.
3 secondary outcomes
Complete Epithelialization of the Index Ulcer
Time frame: Up to Week 6
Time to Complete Healing of the Index Ulcer
Time frame: Up to Week 6
Change in Ulcer-Related Pain Score
Time frame: Baseline and weekly assessments through Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saba Amin principal investigator
Multan Medical And Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet Rich Plasma Dressing and Normal Saline Dressing in people with Chronic Skin Ulcer and Diabetic Foot Ulcer, run by Multan Medical And Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Index Ulcer Area (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.