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

May 16, 2026 updated by: Islam Badry Mohamed, Ain Shams University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11591
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Patients received self-dressing.
Other: Self-dressing
Patients received self-dressing.
Active Comparator: Group B
Patients received a nurse-led dressing.
Other: Nurse-led dressing
Patients received a nurse-led dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete wound healing
Time Frame: 3 months after the procedure
Time to complete wound healing was recorded.
3 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of ulcers healed
Time Frame: 3 months after the procedure
Proportion of ulcers healed within 12 weeks was recorded.
3 months after the procedure
Infection rate
Time Frame: 3 months after the procedure
Infection rate was recorded.
3 months after the procedure
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").
24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

April 1, 2026

Study Completion (Actual)

April 1, 2026

Study Registration Dates

First Submitted

May 16, 2026

First Submitted That Met QC Criteria

May 16, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 16, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 00006379 (207)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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