Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds
NCT ID: NCT06832787
Last Updated: 2025-07-25
Study Results
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Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-07-22
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NPWT Only
Control: Negative Pressure Wound Therapy only
Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
NPWT + Kerecis
Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix
Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Kerecis
Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
NPWT + Delayed Primary Closure with Local Flap
Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy
Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Delayed primary closure with local flap
Delayed primary closure with local flap to close wound
Interventions
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Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Kerecis
Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
Delayed primary closure with local flap
Delayed primary closure with local flap to close wound
Eligibility Criteria
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Inclusion Criteria
* First or last toe ray amputation
* Adequate perfusion (either \>50% stenosis on duplex ultrasound or undergone successful revascularization with \<30% residual stenosis)
Exclusion Criteria
* Venous ulcers
* Heel ulcers
* Osteomyelitis
* Active Infection
* Patients on imunosuppressant
* Patients with known allergy to fish
* Patients unable to give informed consent.
21 Years
100 Years
ALL
No
Sponsors
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Singapore General Hospital
OTHER
Responsible Party
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Principal Investigators
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Jack Kian Ch'ng
Role: PRINCIPAL_INVESTIGATOR
Singapore General Hospital
Locations
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Singapore General Hospital
Singapore, , Singapore
Sengkang General Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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2024/2226
Identifier Type: -
Identifier Source: org_study_id
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