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

NCT ID: NCT04090008

Last Updated: 2019-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-08-01

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.

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

PRP gel

Intervention Type: DRUG

The PRP gel is applied on the ulcer twice per week

Saline dressing

daily dressing of the ulcer with normal saline was done

Group Type: ACTIVE_COMPARATOR

Saline dressing

Intervention Type: DRUG

Normal saline is used for dressing of the ulcer twice a week

Interventions

PRP gel

The PRP gel is applied on the ulcer twice per week

Intervention Type: DRUG

Saline dressing

Normal saline is used for dressing of the ulcer twice a week

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Sameh Emile

Lecturer of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sameh Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

Mansoura103

Identifier Type: -

Identifier Source: org_study_id