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

NCT ID: NCT06867328

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-10
• Study Completion Date: 2025-05-10

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.

Detailed Description

After obtaining approval from the institutional review board and obtaining informed consent from study participants, all patients fulfilling the inclusion criteria were included in the study from the surgery indoor department of Gulab Devi Hospital, Lahore. Baseline characteristics, including age (in years), gender (male/female), and history of comorbidities (hypertension/ischemic heart disease/smoking), were assessed by reviewing previous medical records and taking a detailed history. The duration of diabetes (in years), duration of the wound (weeks), size of the wound (measured using a millimeter scale along the longest axis), and class of chronic diabetic wound (III/IV) were documented.

After wound debridement, patients were randomized into two equal groups by block randomization as follows:

Group A: Patients were managed with normal saline dressing. Group B: Patients were managed with PRP dressing. In this technique, the wound was washed with normal saline, and platelet-rich plasma (prepared from the patient's own blood by the hematology department) was injected into the surrounding wound area twice weekly, followed by the placement of a gauze over it.

Dressing was continued for a period of 6 weeks or until wound healing was achieved, whichever was shorter. To assess healing, all patients in both groups were followed up weekly until 6 weeks (study endpoint). The duration required to achieve wound healing was also documented. Additionally, 6 weeks post-therapy, wound size was reassessed. In cases of non-healing, alternative therapy was provided based on the wound condition and the consultant surgeon's advice. All data were recorded in a predesigned proforma and kept confidential.

Conditions

Diabetic Wounds; Diabetic Ulcers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group PRP Dressing

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.

Group Type: EXPERIMENTAL

Platelet-Rich Plasma (PRP) Dressing

Intervention Type: 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 Normal Saline Dressing

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.

Group Type: ACTIVE_COMPARATOR

Normal Saline Dressing

Intervention Type: 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.

Interventions

Platelet-Rich Plasma (PRP) Dressing

• 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.

Intervention Type: PROCEDURE

Normal Saline Dressing

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulab Devi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Adeel Ahmed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gulab Devi Chest Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

GulabDeviH

Identifier Type: -

Identifier Source: org_study_id