Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds

NCT06832787 | Recruiting

• 1 other identifier: 2024/2226
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Singapore has one of the world's highest diabetes-related lower limb amputation rates in the world. Between 2008 - 2017, 4724/5306 (89.0%) of all major amputations and 6656/7227 (92.1%) of all toe/ray amputations performed in Singapore were for diabetic patients. Diabetic foot ulcers are generally slow to heal and poor wound management may lead to infection and subsequently major amputations. Hence, adequate wound care to achieve wound healing efficiently and effectively is of utmost importance. In the investigators' clinical practice, Negative Pressure Wound Therapy has been the dressing of choice to aid wound closure and prevent infective complications. Drainage of wound exudates helps to reduce and prevent infection, promote granulation tissue proliferation and induce cell growth. When used in combination with dermal substitutes, graft uptake is improved by further promoting proliferation and encouraging tissue regeneration. Wounds can also be closed surgically though primary closure, where the skin is closed and serves as a physical barrier against infection. The technique is not without its pros and cons. Primary closure may decrease healing time and reduce need for additional surgery, but these patients are also at risk of recurrent infection and may require more proximal amputation. These may be circumvented with delayed primary closure, which is the surgical closure of the amputation wound at a delayed timing after amputation. This gives the clinical team time to optimize the wound and ensure that there is no underlying infection prior to closure. The experience of NPWT + Kerecis Omega 3 and delayed primary closure have been positive. To the investigators' current knowledge, there is only one case series reported for the use of fish skin graft in combination with NPWT for the treatment of acute pediatric wounds and two case series for the use of NPWT in diabetic foot wound that has undergone surgical closure. The proposed study would be the first RCT to evaluate effects of combination therapy in both open and closed diabetic foot ulcers.

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic Foot Ulcer; Negative Pressure Wound Therapy; Dermal Substitute; Delayed wound closure

Outcome Measures

Primary Outcomes (1)

• Number of 100% Wound Closure at 12 weeks

  100% Wound Closure defined as re-epithelization without any need for dressing

  12 weeks post-intervention

Secondary Outcomes (6)

• Time in days taken to achieve complete wound closure

  Up to 12 weeks post-intervention

• Change in Wong-Baker FACES® Pain Rating Scale Score from Baseline to 12 weeks

  From time of intervention to 12 weeks post-intervention

• Occurrence of infection during study period

  Up to 12 weeks post-intervention

• Occurrence of further minor amputation during study period

  Up to 12 weeks post-intervention

• Occurrence of major amputation during study period

  Up to 12 weeks post-intervention

Study Arms (3)

NPWT Only

OTHER

Control: Negative Pressure Wound Therapy only

Device: Negative Pressure Wound Therapy

NPWT + Kerecis

ACTIVE COMPARATOR

Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix

Device: Negative Pressure Wound Therapy; Device: Kerecis

NPWT + Delayed Primary Closure with Local Flap

ACTIVE COMPARATOR

Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy

Device: Negative Pressure Wound Therapy; Device: Delayed primary closure with local flap

Interventions

Negative Pressure Wound Therapy DEVICE

NPWT applied over wound without any adjuncts

NPWT + Delayed Primary Closure with Local Flap; NPWT + Kerecis; NPWT Only

Kerecis DEVICE

Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.

NPWT + Kerecis

Delayed primary closure with local flap DEVICE

Delayed primary closure with local flap to close wound

NPWT + Delayed Primary Closure with Local Flap

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-100
• First or last toe ray amputation
• Adequate perfusion (either \>50% stenosis on duplex ultrasound or undergone successful revascularization with \<30% residual stenosis)

You may not qualify if:

• Amputations not at first or last toe
• Venous ulcers
• Heel ulcers
• Osteomyelitis
• Active Infection
• Patients on imunosuppressant
• Patients with known allergy to fish
• Patients unable to give informed consent.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Sengkang General Hospital

Singapore, Singapore

RECRUITING

Related Publications (7)

• Ciprandi G, Kjartansson H, Grussu F, Baldursson BT, Frattaroli J, Urbani U, Zama M. Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. J Wound Care. 2022 Oct 2;31(10):824-831. doi: 10.12968/jowc.2022.31.10.824.

  PMID: 36240798 BACKGROUND

• Aerden D, Vanmierlo B, Denecker N, Brasseur L, Keymeulen B, Van den Brande P. Primary closure with a filleted hallux flap after transmetatarsal amputation of the big toe for osteomyelitis in the diabetic foot: a short series of four cases. Int J Low Extrem Wounds. 2012 Jun;11(2):80-4. doi: 10.1177/1534734612446640. Epub 2012 May 4.

  PMID: 22561521 BACKGROUND

• Blume PA, Paragas LK, Sumpio BE, Attinger CE. Single-stage surgical treatment of noninfected diabetic foot ulcers. Plast Reconstr Surg. 2002 Feb;109(2):601-9. doi: 10.1097/00006534-200202000-00029.

  PMID: 11818842 BACKGROUND

• Berceli SA, Brown JE, Irwin PB, Ozaki CK. Clinical outcomes after closed, staged, and open forefoot amputations. J Vasc Surg. 2006 Aug;44(2):347-351; discussion 352. doi: 10.1016/j.jvs.2006.04.043.

  PMID: 16890866 BACKGROUND

• Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.

  PMID: 33344649 BACKGROUND

• Normandin S, Safran T, Winocour S, Chu CK, Vorstenbosch J, Murphy AM, Davison PG. Negative Pressure Wound Therapy: Mechanism of Action and Clinical Applications. Semin Plast Surg. 2021 Aug;35(3):164-170. doi: 10.1055/s-0041-1731792. Epub 2021 Sep 10.

  PMID: 34526864 BACKGROUND

• Riandini T, Pang D, Toh MPHS, Tan CS, Choong AMTL, Lo ZJ, Chandrasekar S, Tai ES, Tan KB, Venkataraman K. National Rates of Lower Extremity Amputation in People With and Without Diabetes in a Multi-Ethnic Asian Population: a Ten Year Study in Singapore. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):147-155. doi: 10.1016/j.ejvs.2021.09.041. Epub 2021 Dec 14.

  PMID: 34916107 BACKGROUND

Related Links

• NPWT in closed foot wounds

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 Officials

• Jack Kian Ch'ng

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charyl Yap, B.Sc

CONTACT

+65 6576 7986; charyl.yap.j.q@sgh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 18, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)