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

Not Applicable
Completed
Conditions
Diabetic Foot
Interventions
Drug: PRP gel
Drug: Saline dressing
Registration Number
NCT04090008
Lead Sponsor
Mansoura University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PRP gelPRP gelPRP 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.
Saline dressingSaline dressingdaily dressing of the ulcer with normal saline was done
Primary Outcome Measures
NameTimeMethod
Percent reduction in the ulcer size20 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mansoura university hospital

🇪🇬

Mansourah, Dakahlia, Egypt

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