Negative pressure dressings combined with other treatments for diabetic foot ulcers
Tests negative pressure wound therapy combinations in adults with diabetic foot ulcers.
Key facts
- Who runs it
- Singapore General Hospital
- Where
- Singapore2 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds
- Status
- Recruiting
- People taking part
- 75 people, planned
- Started
- 22 Jul 2025
- Planned end
- 30 Jun 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Negative Pressure Wound Therapy
- Kerecis
- Delayed primary closure with local flap
- Record updated
- 25 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a diabetic foot wound after removal of the first or last toe and its foot bone (toe ray amputation).
- Age
- 21 to 100 years
- Sex
- All sexes
- Disease stage
- Diabetic foot wound after a first or last toe ray amputation. Blood flow to the foot must be adequate: either >50% stenosis on duplex ultrasound, or a successful procedure to restore blood flow with <30% narrowing left.
- Earlier treatment
- Must have had a first or last toe ray amputation.
Main reasons for not taking part
- Amputation not at the first or last toe
- Venous ulcers or heel ulcers
- Bone infection (osteomyelitis) or active infection
- Taking drugs that weaken the immune system (immunosuppressants)
- Known allergy to fish, or unable to give informed consent
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Active Infection
- Patients with known allergy to fish
- Amputations not at first or last toe
- Venous ulcers
- Heel ulcers
- Osteomyelitis
- Patients on imunosuppressant
- Patients unable to give informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 100 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 3 groups in the trial
- NPWT OnlyOther group
Control: Negative Pressure Wound Therapy only
Treatment: Negative Pressure Wound Therapy
- NPWT + KerecisExisting treatment, for comparison
Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix
Treatment: Negative Pressure Wound Therapy and Kerecis
- NPWT + Delayed Primary Closure with Local FlapExisting treatment, for comparison
Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy
Treatment: Negative Pressure Wound Therapy and Delayed primary closure with local flap
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds
- Plain-language title
- Negative pressure dressings combined with other treatments for diabetic foot ulcersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Fit questions
- Built from NCT06832787, who can take part
- Record updated
- 25 July 2025