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Clinical Trials/NCT07602491
NCT07602491CompletedNot Applicable

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

Ain Shams University1 site in 1 country60 target enrollmentStarted: October 1, 2025Last updated:
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.
  • •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.

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Islam Badry Mohamed

Lecturer of Vascular Surgery, Ain Shams University, Cairo, Egypt.

Ain Shams University

Study Sites (1)

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