CompletedNot Applicable

Efficacy of Negative Pressure Wound Therapy Versus Conventional Moist Dressings on Diabetic Foot Ulcer Healing Trajectories

Jordan60 participantsStarted 2026-01-01

Plain-language summary

Background: Diabetic foot ulcers (DFUs) are severe, chronic complications of diabetes carrying a high risk of amputation. While Negative Pressure Wound Therapy (NPWT) is an active biophysical treatment, clinical evidence using multidimensional tools in Middle Eastern settings like Jordan has been limited. Methods: A 3-month randomized controlled trial (January-May 2026) was conducted at the National Center for Diabetes, Endocrinology, and Genetics (NCDEG) in Amman, Jordan, involving 60 patients with chronic DFUs. Participants were randomized to either an intervention group receiving NPWT (80-125 mmHg, changed every 4 days) or a control group receiving conventional moist dressings (changed every 2 days). Wound trajectories were assessed using the 13-item Bates-Jensen Wound Assessment Tool (BWAT©).

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 years or older. * Diagnosed with superficial chronic diabetic foot ulcers (partial- or full-thickness) located on the plantar surface, metatarsal heads, or sole (Grade 1/clean ulcers). Had a wound length ranging from 10 to 15 cm. Had controlled diabetes mellitus with stable comorbid conditions (e.g., hypertension or non-end-stage renal disease). * Were able to speak and read Arabic. * Were able to perform activities of daily living (ADLs) independently. * Provided voluntary written informed consent to participate in the study Exclusion Criteria: * Underlying osteomyelitis, Charcot's joint/arthropathy, or DFUs classified as Wagner Grade 3, 4, or 5. * Severe peripheral vascular/arterial diseases, venous insufficiency, or bilateral involvement of both feet. * Coagulopathic conditions, active bleeding tendencies, or severe immunocompromising diseases. * Cognitive or mental impairments preventing informed participation. * Severe diabetic complications (e.g., acute cerebrovascular disease). * Pregnancy, active fever, or acutely infected wounds at baseline.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Bates-Jensen Wound Assessment Tool (BWAT©)

Timeframe: baseline at least 3 mounth post intervention

Trial details

NCT IDNCT07745075

SponsorJerash Private University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-01

View on ClinicalTrials.gov More Diabetic Foot Ulcer Healing Trajectories trials