MedTrace Logo

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

NCT07745075 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-04

No results posted yet for this study

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

  • Diabetic Foot Ulcer Healing Trajectories

Interventions

OTHER

Vacuum-Assisted Closure (VAC / NPWT)

Vacuum-Assisted Closure (VAC / NPWT) 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.

Sponsors & Collaborators

  • Jerash Private University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-05-01
Completion
2026-05-01

Countries

  • Jordan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07745075 on ClinicalTrials.gov