A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers

Mansoura University

Status: Completed

Conditions: Diabetic Foot

Treatments: Drug: PRP gel; Drug: Saline dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04090008

Mansoura103

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

PRP gel

Active Comparator group

Description:

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.

Treatment:

Drug: PRP gel

Saline dressing

Active Comparator group

Description:

daily dressing of the ulcer with normal saline was done

Treatment:

Drug: Saline dressing