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NCT Number: NCT06832787

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

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sengkang General Hospital, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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".

  3. 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

  4. 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

  5. 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

  6. Occurrence of death during study period

    Time frame: Up to 12 weeks post-intervention

    Occurrence of death during follow-up period is recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Charyl Yap, B.Sc

CONTACT

[email protected]

+65 6576 7986

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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