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

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Diabetic Foot Ulcer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06832787

2024/2226

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

NPWT Only

Other group

Description:

Control: Negative Pressure Wound Therapy only

Treatment:

Device: Negative Pressure Wound Therapy

NPWT + Kerecis

Active Comparator group

Description:

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

Treatment:

Device: Kerecis

Device: Negative Pressure Wound Therapy

NPWT + Delayed Primary Closure with Local Flap

Active Comparator group

Description:

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

Treatment:

Device: Delayed primary closure with local flap

Device: Negative Pressure Wound Therapy