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

NCT07745075 | Completed DMC

• 1 other identifier: NPWT vs. Convention-2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Diabetic Foot Ulcer Healing Trajectories

Keywords

Negative pressure wound therapy (NPWT); Vacuum-assisted closure (VAC); Diabetic foot ulcer (DFU); Bates-Jensen Wound Assessment Tool (BWAT©); Glycemic control (HbA1c); Wound healing outcomes

Outcome Measures

Primary Outcomes (1)

• The Bates-Jensen Wound Assessment Tool (BWAT©)

  Formerly known as the Pressure Sore Status Tool (PSST©), the BWAT provides objective, numerical scoring for wound tissue characteristics. It demonstrates high validity and inter-rater reliability (correlation coefficients ranging from 0.80 to 0.90)

  baseline at least 3 mounth post intervention

Study Arms (2)

Control Group

NO 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 Group

EXPERIMENTAL

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.

Other: Vacuum-Assisted Closure (VAC / NPWT)

Interventions

Vacuum-Assisted Closure (VAC / NPWT) OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jerash Private University: lead

Study Sites (1)

the National Center for Diabetes, Endocrinology, and Genetics (NCDEG)

Amman, Dours, 009627, Jordan

Location

Related Publications (1)

• Abirami, R. S., Bakyalakshmi, S., Swarnalatha, M., Vaishnavi, S. K., & G, V. (2024). A comparative study of standard dressing verses vac therapy dressing in diabetic foot ulcer patients. World Journal of Biology Pharmacy and Health Sciences, 19(3), 620-628. https://doi.org/10.30574/wjbphs.2024.19.3.0620 AlAyed, M. Y., Younes, N., Al-Smady, M., Khader, Y. S., Robert, A. A., & Ajlouni, K. (2017). Prevalence of foot ulcers, foot at risk and associated risk factors among Jordanian diabetics. Current Diabetes Reviews, 13(2), 182-191. https://doi.org/10.2174/1573399812666151210143140 Dharaneesh, S. S., Sridhar, J., Kumar, D., Premnath, P., Kanth, A., & S, S. (2025). Comparison of vacuum-assisted closure (VAC) therapy and conventional dressing on wound healing in diabetic foot ulcer: A randomized controlled trial. Journal of Neonatal Surgery, 14, Article 2087. https://doi.org/10.52783/jns.v14.2087 Mairghani, M., Elmusharaf, K., Patton, D., Burns, J., Eltahir, O., Jassim, G., & Moore, Z. (2017). The prevalence and incidence of diabetic foot ulcers among five countries in the Arab world: A systematic review. Journal of Wound Care, 26(Sup9), S27-S34. https://doi.org/10.12968/jowc.2017.26.sup9.s27 Nirupam, N., & Vinayak, K. (2022). Vacuum-assisted closure vs conventional open treatment in diabetic foot ulcer-A comparative study. Global Journal of Medical Students, 2(3), Article 82. https://doi.org/10.52314/gjms.2022.v2i3.82 Ravisankar, M. S., Sridhar, J., & Babu, D. S. G. (2022). Comparative study of Vac dressing with moist gauze dressing in the treatment of diabetic foot ulcer in tertiary care center. International Journal of Health Sciences, 6(S6), 10387-10395. https://doi.org/10.53730/ijhs.v6ns6.10387 Rodríguez Angulo, A., Caballero-Alvarado, J., Sarmiento-Falen, J., & Zavaleta-Corvera, C. (2025). Comparative assessment of negative pressure wound therapy versus standard treatment in diabetic foot ulcers. Journal of Wound, Ostomy and Continence Nursing, 52(3), Article e1164

  RESULT

Related Links

• AlAyed, M. Y., Younes, N., Al-Smady, M., Khader, Y. S., Robert, A. A., \& Ajlouni, K. (2017). Prevalence of foot ulcers, foot at risk and associated risk factors among Jordanian diabetics. Current Diabetes Reviews, 13(2), 182-191. https://doi.org/10.2174/

MeSH Terms

Conditions

Diabetic Foot

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Jawad Ahmad Abu-Shennar Assistant Professor of Surgical Diseases Nursing & Diabetes Nursing. Faculty of Nursing, Jerash University, Jerash

Model Details: Interventions 6.1 Group A: 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. 6.2 Group B: Conventional Dressing 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. 7\. Outcome Measures and Study Instruments 7.1 Study Instruments Data were gathered us

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 4, 2026
• Study Start: January 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)