Diabetic Foot
Conditions
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.
Interventions
DRUGPRP gel
The PRP gel is applied on the ulcer twice per week
DRUGSaline dressing
Normal saline is used for dressing of the ulcer twice a week
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in the ulcer size | 20 weeks | the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment |
Countries
Egypt
Outcome results
None listed