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Completed

NCT Number: NCT07602491

Dressing Method (Self-dressing vs. Nurse-led Dressing) on Healing Outcomes in Diabetic Foot Ulcers

This study aimed to compare the efficacy of self-dressing and nurse-led dressing on healing outcomes in diabetic foot ulcers (DFUs) .

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Key information

Conditions

Dressing Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcers Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Healing Leg Ulcer Nurse-led Dressing Self-dressing Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11591, Egypt

About this study

Diabetic foot ulcers (DFUs) are among the most severe and persistent complications linked to diabetes.

Wound care is essential in managing diabetic foot wounds, involving the cleansing of the wound with normal saline via aseptic procedures and the application of contemporary wound care methods that facilitate a moist healing environment.

The choice of wound dressings is crucial in the management of diabetic wounds.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years.
  • Admitted with type 1 or type 2 diabetes mellitus.
  • Superficial or moderate diabetic foot ulcer (Wagner grade 1-2).
  • Ankle-Brachial Pressure Index (ABI) ≥0.7.
  • Mental competence and literacy sufficient to understand instructions.
  • Had adequate visual and motor skills to perform self-dressing.

Exclusion criteria

  • Severe ulcers (Wagner grade ≥3).
  • Systemic infection.
  • Critical limb ischemia.
  • Patients requiring urgent surgical intervention or amputation.
  • Inability to perform self-care due to physical or cognitive impairment.
  • Refusal to participate or withdrawal of informed consent.

Treatment and study plan

Self-dressing

Other

Patients received self-dressing.

Nurse-led dressing

Other

Patients received a nurse-led dressing.

Primary outcomes

  1. Time to complete wound healing

    Time frame: 3 months after the procedure

    Time to complete wound healing was recorded.

Secondary outcomes

  1. Proportion of ulcers healed

    Time frame: 3 months after the procedure

    Proportion of ulcers healed within 12 weeks was recorded.

  2. Infection rate

    Time frame: 3 months after the procedure

    Infection rate was recorded.

  3. Degree of pain

    Time frame: 24 hours postoperatively

    Each patient was instructed about postoperative pain assessment with the Visual Analog Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Assessment of Dressing Method (Self-dressing vs. Nurse-led Dressing) on Healing Outcomes in Diabetic Foot Ulcers: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

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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