Clinical trial NCT06867328: Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds
Official title: Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Wounds
Diabetic Ulcers
Keywords: Platelet-Rich Plasma (PRP)
Normal Saline Dressing
Diabetic Ulcers
Chronic Wounds
Lead sponsor: Gulab Devi Hospital
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Wound Healing
timeFrame: Evaluated weekly for up to 6 weeks
Secondary outcomes:
measure: Duration to Achieve Wound Healing
timeFrame: Measured at the end of 6 weeks or at the point of complete wound healing, whichever occurs first.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Gulab Devi Chest Hospital
state: Punjab
Study officials:
References: