Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds

NCT06867328 | Completed

• 1 other identifier: GulabDeviH
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic diabetic wounds are a major health concern, often taking a long time to heal and increasing the risk of complications like infections and amputations. This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) Dressing versus Normal Saline Dressing in the treatment of chronic diabetic wounds. PRP is a treatment derived from the patient's own blood that contains growth factors, which may accelerate wound healing. Participants with chronic diabetic wounds will be randomly assigned to receive either PRP dressing or normal saline dressing. The study will measure the rate of wound healing and the time taken to achieve complete healing in both groups. It is hypothesized that PRP dressing will lead to faster and more effective wound healing compared to normal saline dressing. Findings from this research could help improve wound care strategies for diabetic patients and provide evidence for a more effective treatment approach in clinical practice.

Conditions

Diabetic Wounds; Diabetic Ulcers

Keywords

Platelet-Rich Plasma (PRP); Normal Saline Dressing; Diabetic Ulcers; Chronic Wounds

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Wound healing will be assessed based on the formation of pinkish granulation tissue completely covering the wound. The healing status will be determined by a consultant surgeon through visual inspection.

  Evaluated weekly for up to 6 weeks

Secondary Outcomes (1)

• Duration to Achieve Wound Healing

  Measured at the end of 6 weeks or at the point of complete wound healing, whichever occurs first.

Study Arms (2)

Group PRP Dressing

EXPERIMENTAL

Patients in this group will receive platelet-rich plasma (PRP) dressing, which involves the application of autologous PRP to the chronic diabetic wound site. PRP will be prepared from the patient's own blood and applied twice weekly after wound debridement.

Procedure: Platelet-Rich Plasma (PRP) Dressing

Group Normal Saline Dressing

ACTIVE COMPARATOR

Patients in this group will receive normal saline dressing, which consists of cleansing the wound with normal saline followed by application of sterile gauze. This will be performed twice weekly after wound debridement.

Procedure: Normal Saline Dressing

Interventions

Platelet-Rich Plasma (PRP) Dressing PROCEDURE

* PRP will be prepared by centrifugation of 20 mL venous blood with an anticoagulant. * The extracted PRP will be applied twice weekly to the wound. * A sterile gauze will be placed over the wound after PRP application. * Treatment will continue for up to 6 weeks or until wound healing is achieved.

Group PRP Dressing

Normal Saline Dressing PROCEDURE

Wound will be cleansed with normal saline and covered with sterile gauze. * Dressing changes will be done twice weekly following wound debridement. * Treatment will continue for up to 6 weeks or until wound healing is achieved.

Group Normal Saline Dressing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60 years.
• Either male or female.
• Chronic diabetic wound.
• Wagner class III and IV.

You may not qualify if:

• Wound sustained \< 6 weeks from time of presentation.
• Previous history of PRP dressing use, assessed by reviewing previous medical records.
• History of hypersensitivity to PRP, assessed by reviewing previous medical records.
• Burn injury, assessed by reviewing previous medical records.
• Class I, II and V.

Sponsors & Collaborators

• Gulab Devi Hospital: lead

Study Sites (1)

Gulab Devi Chest Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: November 10, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 10, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)