DressingNCT07602491
Dressing Method (Self-dressing vs. Nurse-led Dressing) on Healing Outcomes in Diabetic Foot Ulcers
A study testing Self-dressing and Nurse-led dressing in people with Dressing and Self-dressing, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy of self-dressing and nurse-led dressing on healing outcomes in diabetic foot ulcers (DFUs) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dressing, Self-dressing, Nurse-led Dressing
- What is being tested?
- Self-dressing and Nurse-led dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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) .
Read the 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.
- Conditions
- Dressing, Self-dressing, Nurse-led Dressing, Healing, Diabetic Foot Ulcers
- Being tested
- Self-dressing, Nurse-led dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-dressingOther
Patients received self-dressing.
Nurse-led dressingOther
Patients received a nurse-led dressing.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients received self-dressing. Receives: Other: Self-dressing |
| Group B | Active comparator | Patients received a nurse-led dressing. Receives: Other: Nurse-led dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound healing
Time to complete wound healing was recorded.
Measured: 3 months after the procedure
Secondary outcomes (3)
Proportion of ulcers healed
Proportion of ulcers healed within 12 weeks was recorded.
Measured: 3 months after the procedure
Infection rate
Infection rate was recorded.
Measured: 3 months after the procedure
Degree of pain
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").
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DressingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Badry Mohamed, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602491
- Sponsor's protocol ID
- IRB 00006379 (207)
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dressing Method (Self-dressing vs. Nurse-led Dressing) on Healing Outcomes in Diabetic Foot Ulcers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07602491
- Acronym / sponsor ID
- IRB 00006379 (207)
- Conditions
- Dressing, Self-dressing, Nurse-led Dressing, Healing, Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Self-dressingPatients received self-dressing. |
| Group B | Active comparator | Other: Nurse-led dressingPatients received a nurse-led dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-dressingPatients received self-dressing. | Other | Group A |
| Nurse-led dressingPatients received a nurse-led dressing. | Other | Group B |
Primary outcome
Time to complete wound healing
Time frame: 3 months after the procedure
Time to complete wound healing was recorded.
3 secondary outcomes
Proportion of ulcers healed
Time frame: 3 months after the procedure
Infection rate
Time frame: 3 months after the procedure
Degree of pain
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-dressing and Nurse-led dressing in people with Dressing and Self-dressing, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound healing (time frame: 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.