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Completed
NCT07745075
Efficacy of Negative Pressure Wound Therapy Versus Conventional Moist Dressings on Diabetic Foot Ulcer Healing Trajectories
Conditions: Diabetic Foot Ulcer Healing Trajectories
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Jerash Private University
Location: the National Center for Diabetes, Endocrinology, and Genetics (NCDEG) Amman Dours
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©).
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07745075). StuddyBuddy aggregates publicly available trial information.