A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers
- Conditions
- Diabetic Foot
- Interventions
- Drug: PRP gelDrug: Saline dressing
- Registration Number
- NCT04090008
- Lead Sponsor
- Mansoura University
- Brief Summary
New treatments for persistent DFU have emerged, among which are the bioengineered skin substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators, and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound healing since the last decade of the 20th century. This randomized trial was conducted to assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer in comparison to regular dressing with saline as a control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- adult patients of both sexes aging below 70 years with non-infected chronic foot ulcer confined to one anatomical site. Chronicity was defined as non-healing ulcer for twelve or more weeks
- Patients with chronic limb ischemia.
- Evidence of osteomyelitis in the affected foot
- Exposed tendons, ligaments or bones at the base of ulcer
- Patients who received radiotherapy or chemotherapy at time of study or within 3 months of its beginning.
- Patients having low peripheral platelet count, low serum albumin level or low hemoglobin level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRP gel PRP gel PRP gel was applied to the ulcer twice per week after preparation and then the ulcer was covered with Vaseline gauze, few layers of sterile gauze and crepe bandage. Saline dressing Saline dressing daily dressing of the ulcer with normal saline was done
- Primary Outcome Measures
Name Time Method Percent reduction in the ulcer size 20 weeks the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mansoura university hospital
🇪🇬Mansourah, Dakahlia, Egypt