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

Not Applicable

Recruiting

• Conditions: Diabetic Foot Ulcer

• Registration Number: NCT06832787
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-03-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of 100% Wound Closure at 12 weeks	12 weeks post-intervention	100% Wound Closure defined as re-epithelization without any need for dressing

Secondary Outcome Measures

Name	Time	Method
Time in days taken to achieve complete wound closure	Up to 12 weeks post-intervention	Time (in days) taken from intervention to 100% wound closure
Change in Wong-Baker FACES® Pain Rating Scale Score from Baseline to 12 weeks	From time of intervention to 12 weeks post-intervention	Pain score is measured using the Wong-Baker FACES® Pain Rating Scale. Participants will be asked at baseline, and at 4, 8 and 12 weeks subsequently. 0 corresponds to "no pain", and 10 corresponds to "worst pain imaginable".
Occurrence of infection during study period	Up to 12 weeks post-intervention	Occurrence of any infection at index wound during follow-up period is recorded
Occurrence of further minor amputation during study period	Up to 12 weeks post-intervention	Occurrence of further minor amputation at index wound during follow-up period is recorded
Occurrence of major amputation during study period	Up to 12 weeks post-intervention	Occurrence of major amputation at index limb during follow-up period is recorded
Occurrence of death during study period	Up to 12 weeks post-intervention	Occurrence of death during follow-up period is recorded

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 SG, Singapore

Sengkang General Hospital; 🇸🇬 SG, Singapore