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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04090008
Other study ID # Mansoura103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date August 1, 2019

Study information

Verified date September 2019
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 1, 2019
Est. primary completion date February 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
PRP gel
The PRP gel is applied on the ulcer twice per week
Saline dressing
Normal saline is used for dressing of the ulcer twice a week

Locations

Country Name City State
Egypt Mansoura university hospital Mansourah Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent reduction in the ulcer size the difference between ulcer size before and after treatment subdivided by the ulcer size before treatment 20 weeks
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