Efficacy of Negative Pressure Wound Therapy Versus Conventional Moist Dressings on Diabetic Foot Ulcer Healing Trajectories | NCT07745075

NCT07745075

Overview

NCT ID: NCT07745075
Lead Sponsor: Jerash Private UniversityOTHER
Official Title: Efficacy of Negative Pressure Wound Therapy Versus Conventional Moist Dressings on Diabetic Foot Ulcer Healing Trajectories: A Randomized Controlled Trial Evaluating Clinical and Biophysical Outcomes
Brief 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©).
Conditions

Status and Timeline

Status: Completed
Last Update Posted: Aug 4, 2026Actual
Start Date: Jan 1, 2026Actual
Primary Completion Date: May 1, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Actual
Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: No data available
Locations: the National Center for Diabetes, Endocrinology, and Genetics (NCDEG)

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Participant Group/Arms

Control GroupNo Intervention

Patients assigned to the control group received conventional wound dressings applied under standard aseptic protocols on an alternate-day schedule (every 2 days) during their hospital stay.

Intervention GroupExperimental

Following initial surgical debridement in the operating room, a sterile foam dressing was applied to the wound bed under aseptic conditions and secured with an adhesive drape to establish an airtight seal. An evacuation tube embedded within the foam was connected to a vacuum unit, delivering continuous sub-atmospheric negative pressure ranging between 80 and 125 mmHg for 96 hours. Exudate was continuously collected into a sealed canister, transforming open ulcerations into controlled, closed, moist healing environments. Dressings were routinely changed under sterile conditions every 4 days during the inpatient stay.

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