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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07602491
Enrollment
60
Registered
2026-05-22
Start date
2025-10-01
Completion date
2026-04-01
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERSelf-dressing

Patients received self-dressing.

OTHERNurse-led dressing

Patients received a nurse-led dressing.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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) ≥0.7. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Time to complete wound healing3 months after the procedureTime to complete wound healing was recorded.

Secondary

MeasureTime frameDescription
Proportion of ulcers healed3 months after the procedureProportion of ulcers healed within 12 weeks was recorded.
Infection rate3 months after the procedureInfection rate was recorded.
Degree of pain24 hours postoperativelyEach 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").

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026