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

NCT07602491 | Completed

• 1 other identifier: IRB 00006379 (207)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dressing; Self-dressing; Nurse-led Dressing; Healing; Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Time to complete wound healing

  Time to complete wound healing was recorded.

  3 months after the procedure

Secondary Outcomes (3)

• Proportion of ulcers healed

  3 months after the procedure

• Infection rate

  3 months after the procedure

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

Patients received self-dressing.

Other: Self-dressing

Group B

ACTIVE COMPARATOR

Patients received a nurse-led dressing.

Other: Nurse-led dressing

Interventions

Self-dressing OTHER

Patients received self-dressing.

Group A

Nurse-led dressing OTHER

Patients received a nurse-led dressing.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Vascular Surgery, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 16, 2026
• First Posted: May 22, 2026
• Study Start: October 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)