Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

NCT06721754 | Recruiting DMC

• 2 other identifiers: 7269292024105
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs). The main questions it aims to answer are:

• Will there be a difference in the number of major amputations between the groups during the first year?
• Will one of the treatments require more surgeries and longer hospital stays? All participants will:
• be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery
• be followed closely at the out-patient clinic for one year after treatment

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Negative Pressure Wound Treatment; Randomized Controlled Trial; Standard Wound Treatment; Amputation

Outcome Measures

Primary Outcomes (1)

• Number of lower extremity amputations

  The study will compare rates of lower extremity amputations within one year after two different treatments for diabetes related foot ulcers.

  One year from inclusion

Secondary Outcomes (7)

• Mortality

  One year.

• Wound healing

  One year.

• Complications

  One year.

• Number of surgeries

  One year.

• Length of hospital stay

  One year.

Study Arms (2)

Standard Wound Treatment

NO INTERVENTION

Negative Pressure Wound Treatment

ACTIVE COMPARATOR

Procedure: Negative Pressure Wound Treatment

Interventions

Negative Pressure Wound Treatment PROCEDURE

Negative Pressure Wound Treatment promotes healing by applying subatmospheric pressure to reduce inflammatory exudate and stimulate granulation tissue.

Also known as: VAC

Negative Pressure Wound Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation

You may not qualify if:

• Previous leg amputation due to diabetes
• Unable to ambulate on feet
• Unlikely to adhere to treatment and/or follow-up
• Unable to complete questionnaire
• Active or ongoing cancer treatment
• In need of amputation at a higher level than metatarsal or more than two metatarsals

Sponsors & Collaborators

• University Hospital, Akershus: lead
• University of Oslo: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• Ostfold Hospital Trust: collaborator

Study Sites (2)

Department of Orthopedic Surgery, Akershus University Hospital

Oslo, Nordbyhagen, 1478, Norway

RECRUITING

Ostfold Hospital

Grålum, 1714, Norway

NOT YET RECRUITING

Related Publications (9)

• Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3266. doi: 10.1002/dmrr.3266.

  PMID: 32176447 BACKGROUND

• Schaper NC, van Netten JJ, Apelqvist J, Bus SA, Fitridge R, Game F, Monteiro-Soares M, Senneville E; IWGDF Editorial Board. Practical guidelines on the prevention and management of diabetes-related foot disease (IWGDF 2023 update). Diabetes Metab Res Rev. 2024 Mar;40(3):e3657. doi: 10.1002/dmrr.3657. Epub 2023 May 27.

  PMID: 37243927 BACKGROUND

• Seidel D, Storck M, Lawall H, Wozniak G, Mauckner P, Hochlenert D, Wetzel-Roth W, Sondern K, Hahn M, Rothenaicher G, Kronert T, Zink K, Neugebauer E. Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT. BMJ Open. 2020 Mar 24;10(3):e026345. doi: 10.1136/bmjopen-2018-026345.

  PMID: 32209619 BACKGROUND

• Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.

  PMID: 16291063 BACKGROUND

• Woods TJ, Tesfay F, Speck P, Kaambwa B. Economic evaluations considering costs and outcomes of diabetic foot ulcer infections: A systematic review. PLoS One. 2020 Apr 30;15(4):e0232395. doi: 10.1371/journal.pone.0232395. eCollection 2020.

  PMID: 32353082 BACKGROUND

• Kerr M, Rayman G, Jeffcoate WJ. Cost of diabetic foot disease to the National Health Service in England. Diabet Med. 2014 Dec;31(12):1498-504. doi: 10.1111/dme.12545. Epub 2014 Aug 1.

  PMID: 24984759 BACKGROUND

• Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015 Oct;38(10):1852-7. doi: 10.2337/dc15-0536. Epub 2015 Jul 22.

  PMID: 26203063 BACKGROUND

• Armstrong DG, Swerdlow MA, Armstrong AA, Conte MS, Padula WV, Bus SA. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020 Mar 24;13(1):16. doi: 10.1186/s13047-020-00383-2.

  PMID: 32209136 BACKGROUND

• Thorud JC, Plemmons B, Buckley CJ, Shibuya N, Jupiter DC. Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review. J Foot Ankle Surg. 2016 May-Jun;55(3):591-9. doi: 10.1053/j.jfas.2016.01.012. Epub 2016 Feb 19.

  PMID: 26898398 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Per-Henrik Randsborg, Professor; MD

  University Hospital, Akershus

  STUDY DIRECTOR

Central Study Contacts

Monica A Sailer, MD

CONTACT

+47 45614728; monica_sailer@yahoo.no

Per-Henrik Randsborg Randsborg, Professor, MD

CONTACT

+47 97040480; per-henrik.randsborg@ahus.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: December 6, 2024
• Study Start: January 2, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)