Chronic Skin Ulcer, Diabetic Foot Ulcer
Conditions
Keywords
Platelet Rich Plasma, Normal Saline Dressing, Wound Healing, Ulcer Area Reduction, Complete Epithelialization
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.
Interventions
BIOLOGICALPlatelet 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.
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.
Sponsors
Multan Medical And Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Reduction in Index Ulcer Area | 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Epithelialization of the Index Ulcer | 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. |
| Time to Complete Healing of the Index Ulcer | Up to Week 6 | Time (in days) from randomization/baseline to first documented complete epithelialization among index ulcers that achieve closure during follow-up. |
| Change in Ulcer-Related Pain Score | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORSaba Amin
Multan Medical And Dental College
Outcome results
None listed