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

Sponsor
Singapore General Hospital
Study ID
NCT06832787
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Negative Pressure Wound Therapy — DEVICE
    NPWT applied over wound without any adjuncts
  • Kerecis — DEVICE
    Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
  • Delayed primary closure with local flap — DEVICE
    Delayed primary closure with local flap to close wound

Study Details

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.

Key Dates

First listed
Feb 18, 2025
Start date
Jul 22, 2025
Status verified
Feb 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: NPWT Only
    Control: Negative Pressure Wound Therapy only
  • Active Comparator: NPWT + Kerecis
    Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix
  • Active Comparator: NPWT + Delayed Primary Closure with Local Flap
    Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy

Primary Outcome Measure

Number of 100% Wound Closure at 12 weeks [ Time Frame: 12 weeks post-intervention ]

Central Contacts

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