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

A Randomized Controlled Trial on Platelet Rich Plasma Gel Compared to Normal Saline Dressing of Diabetic Foot Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot
• Intervention / Treatment: Drug: PRP gel; Drug: Saline dressing

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansourah, Dakahlia, Egypt, 35516
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: PRP gel; The PRP gel is applied on the ulcer twice per week
Active Comparator: Saline dressing; daily dressing of the ulcer with normal saline was done	Drug: Saline dressing; Normal saline is used for dressing of the ulcer twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent reduction in the ulcer size	the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment	20 weeks

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: Mansoura103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No