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

July 24, 2025 updated by: Singapore General Hospital

Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • SG, Singapore, 169856
        • Recruiting
        • Singapore General Hospital
        • Contact:
        • Principal Investigator:
          • Jack Kian Ch'ng
      • SG, Singapore
        • Recruiting
        • Sengkang General Hospital
        • Contact:
        • Principal Investigator:
          • Jiajun Feng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: NPWT Only
Control: Negative Pressure Wound Therapy only
Device: Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Active Comparator: NPWT + Kerecis
Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix
Device: Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Device: Kerecis
Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
Active Comparator: NPWT + Delayed Primary Closure with Local Flap
Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy
Device: Negative Pressure Wound Therapy
NPWT applied over wound without any adjuncts
Device: Delayed primary closure with local flap
Delayed primary closure with local flap to close wound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of 100% Wound Closure at 12 weeks
Time Frame: 12 weeks post-intervention
100% Wound Closure defined as re-epithelization without any need for dressing
12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in days taken to achieve complete wound closure
Time Frame: Up to 12 weeks post-intervention
Time (in days) taken from intervention to 100% wound closure
Up to 12 weeks post-intervention
Change in Wong-Baker FACES® Pain Rating Scale Score from Baseline to 12 weeks
Time Frame: 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".
From time of intervention to 12 weeks post-intervention
Occurrence of infection during study period
Time Frame: Up to 12 weeks post-intervention
Occurrence of any infection at index wound during follow-up period is recorded
Up to 12 weeks post-intervention
Occurrence of further minor amputation during study period
Time Frame: Up to 12 weeks post-intervention
Occurrence of further minor amputation at index wound during follow-up period is recorded
Up to 12 weeks post-intervention
Occurrence of major amputation during study period
Time Frame: Up to 12 weeks post-intervention
Occurrence of major amputation at index limb during follow-up period is recorded
Up to 12 weeks post-intervention
Occurrence of death during study period
Time Frame: Up to 12 weeks post-intervention
Occurrence of death during follow-up period is recorded
Up to 12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Jack Kian Ch'ng, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

February 18, 2025

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/2226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to Personal Data Protection Act.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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