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Completed

NCT Number: NCT06867328

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

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.

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Key information

Conditions

Diabetic Wounds Diabetic Ulcers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulab Devi Chest Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Wound Healing

    Time frame: Evaluated weekly for up to 6 weeks

    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.

Secondary outcomes

  1. Duration to Achieve Wound Healing

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

    The duration required for complete wound healing (formation of granulation tissue covering the entire wound) will be recorded in weeks for each patient in both groups.

Sponsors and collaborators

Lead sponsor

Gulab Devi Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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