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

NCT04090008 | Completed

• 1 other identifier: Mansoura103
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percent reduction in the ulcer size

  the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment

  20 weeks

Study Arms (2)

PRP gel

ACTIVE COMPARATOR

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

Saline dressing

ACTIVE COMPARATOR

daily dressing of the ulcer with normal saline was done

Drug: Saline dressing

Interventions

PRP gel DRUG

The PRP gel is applied on the ulcer twice per week

PRP gel

Saline dressing DRUG

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

Saline dressing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Sameh Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of surgery

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: August 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: August 1, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

EG (1)