Efficacy of Platelet-rich Plasma Versus Platelet-rich Fibrin Versus Conventional Treatment in Chronic Non-healing Skin Ulcers: a Comparative Study

NCT06281483 NA RECRUITING

To compare the therapeutic efficacy of PRP and PRF: two relatively newer modalities in the management of chronic non-healing ulcers versus conventional treatment.

Details

Lead sponsor	Kafrelsheikh University
Phase	NA
Status	RECRUITING
Enrolment	36
Start date	2024-01-01
Completion	2026-01

Conditions

• Chronic Non-healing Skin Ulcers

Interventions

• platelet-rich plasma
• platelet-rich fibrin
• Surgical debridement, normal saline washing and dressing coverage

Primary outcomes

• Objective assessment of ulcer size for effectiveness, using Image J software. — Four months of follow up after eight sessions of treatment (six months total)
  Photographs will be obtained at baseline, one month after and at end of eight sessions (two months) with a Nikon D3300 AF-P 18-55 VR 24.2 Megapixels® digital camera and will be standardized for light and distance from the ulcer.
• Pain assessment — Four months of follow up after eight sessions of treatment (six months total)
  Pain assessment will be done using Visual analogue scale (scale: 0-10).The Visual analogue scale provides a continuous scale for subjective magnitude estimation and consists of a straight line, the limits of which carry a verbal description of each extreme of the pain to be evaluated. The line is usually 10 cm long and vertical. The Visual analogue scale is often used to evaluate the analgesic properties of various treatments and accomplishes this by measuring either pain relief or pain severity.
• Any adverse effects related to treatment modality — Four months of follow up after eight sessions of treatment (six months total)
  Any adverse effects related to therapy will be recorded immediately at each sitting and statistically analyzed for comparison between groups of trial.

Countries

Egypt