Diabetic Foot UlcerNCT06832787
Evaluation of Combinational Use of Negative Pressure Wound Therapy (NPWT) for Diabetic Foot Wounds
A study testing Negative Pressure Wound Therapy, Kerecis and Delayed primary closure with local flap in people with Diabetic Foot Ulcer, run by Singapore General Hospital at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Negative Pressure Wound Therapy, Kerecis and Delayed primary closure with local flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesSingapore
- Study dates
- 22 Jul 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Charyl Yap, +65 65797986, charyl.yap.j.q@sgh.com.sg
Jack Kian Ch'ng
- Recruiting
Sengkang General Hospital
Singapore
Michelle Mo, +65 6930 5333, michelle.m.j@skh.com.sg
Jiajun Feng
About this study
Official title: 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.
Read more
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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Negative Pressure Wound Therapy, Kerecis, Delayed primary closure with local flap
- Keywords
- Diabetic Foot Ulcer, Negative Pressure Wound Therapy, Dermal Substitute, Delayed wound closure
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
NPWT applied over wound without any adjuncts
KerecisDevice
Kerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute.
Delayed primary closure with local flapDevice
Delayed primary closure with local flap to close wound
| Study group | Role | What they receive |
|---|---|---|
| NPWT Only | Other | Control: Negative Pressure Wound Therapy only Receives: Device: Negative Pressure Wound Therapy |
| NPWT + Kerecis | Active comparator | Combinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix Receives: Device: Negative Pressure Wound Therapy; Device: Kerecis |
| NPWT + Delayed Primary Closure with Local Flap | Active comparator | Combinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy Receives: Device: Negative Pressure Wound Therapy; Device: Delayed primary closure with local flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of 100% Wound Closure at 12 weeks
100% Wound Closure defined as re-epithelization without any need for dressing
Measured: 12 weeks post-intervention
Secondary outcomes (6)
Time in days taken to achieve complete wound closure
Time (in days) taken from intervention to 100% wound closure
Measured: Up to 12 weeks post-intervention
Change in Wong-Baker FACES® Pain Rating Scale Score from Baseline to 12 weeks
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".
Measured: From time of intervention to 12 weeks post-intervention
Occurrence of infection during study period
Occurrence of any infection at index wound during follow-up period is recorded
Measured: Up to 12 weeks post-intervention
Occurrence of further minor amputation during study period
Occurrence of further minor amputation at index wound during follow-up period is recorded
Measured: Up to 12 weeks post-intervention
Occurrence of major amputation during study period
Occurrence of major amputation at index limb during follow-up period is recorded
Measured: Up to 12 weeks post-intervention
Occurrence of death during study period
Occurrence of death during follow-up period is recorded
Measured: Up to 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start22 Jul 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack Kian Ch'ng, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832787
- Sponsor's protocol ID
- 2024/2226
- Status last verified
- Feb 2025
- First submitted
- 11 Feb 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to Personal Data Protection Act.
Publications
Ciprandi G, Kjartansson H, Grussu F, Baldursson BT, Frattaroli J, Urbani U, Zama M. Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. J Wound Care. 2022 Oct 2;31(10):824-831. doi: 10.12968/jowc.2022.31.10.824.
PubMed 36240798Aerden D, Vanmierlo B, Denecker N, Brasseur L, Keymeulen B, Van den Brande P. Primary closure with a filleted hallux flap after transmetatarsal amputation of the big toe for osteomyelitis in the diabetic foot: a short series of four cases. Int J Low Extrem Wounds. 2012 Jun;11(2):80-4. doi: 10.1177/1534734612446640. Epub 2012 May 4.
PubMed 22561521Blume PA, Paragas LK, Sumpio BE, Attinger CE. Single-stage surgical treatment of noninfected diabetic foot ulcers. Plast Reconstr Surg. 2002 Feb;109(2):601-9. doi: 10.1097/00006534-200202000-00029.
PubMed 11818842Berceli SA, Brown JE, Irwin PB, Ozaki CK. Clinical outcomes after closed, staged, and open forefoot amputations. J Vasc Surg. 2006 Aug;44(2):347-351; discussion 352. doi: 10.1016/j.jvs.2006.04.043.
PubMed 16890866Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.
PubMed 33344649Normandin S, Safran T, Winocour S, Chu CK, Vorstenbosch J, Murphy AM, Davison PG. Negative Pressure Wound Therapy: Mechanism of Action and Clinical Applications. Semin Plast Surg. 2021 Aug;35(3):164-170. doi: 10.1055/s-0041-1731792. Epub 2021 Sep 10.
PubMed 34526864Riandini T, Pang D, Toh MPHS, Tan CS, Choong AMTL, Lo ZJ, Chandrasekar S, Tai ES, Tan KB, Venkataraman K. National Rates of Lower Extremity Amputation in People With and Without Diabetes in a Multi-Ethnic Asian Population: a Ten Year Study in Singapore. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):147-155. doi: 10.1016/j.ejvs.2021.09.041. Epub 2021 Dec 14.
PubMed 34916107
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds
- ClinicalTrials.gov ID
- NCT06832787
- Acronym / sponsor ID
- 2024/2226
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Negative Pressure Wound Therapy, Dermal Substitute, Delayed wound closure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPWT Only | Other | Device: Negative Pressure Wound TherapyControl: Negative Pressure Wound Therapy only |
| NPWT + Kerecis | Active comparator | Device: Negative Pressure Wound Therapy, Device: KerecisCombinational Therapy of Negative Pressure Wound Therapy + application of Kerecis Omega 3 Wound Matrix |
| NPWT + Delayed Primary Closure with Local Flap | Active comparator | Device: Negative Pressure Wound Therapy, Device: Delayed primary closure with local flapCombinational Therapy of Delayed Primary Closure with Local Flap and Negative Pressure Wound Therapy |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- Amputations not at first or last toe
- Venous ulcers
- Heel ulcers
- Osteomyelitis
- Active Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative Pressure Wound TherapyNPWT applied over wound without any adjuncts | Device | NPWT + Delayed Primary Closure with Local Flap, NPWT + Kerecis, NPWT Only |
| KerecisKerecis Omega3 Wound Dressing is derived from fish skin and is used as a dermal substitute. | Device | NPWT + Kerecis |
| Delayed primary closure with local flapDelayed primary closure with local flap to close wound | Device | NPWT + Delayed Primary Closure with Local Flap |
Primary outcome
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
6 secondary outcomes
Time in days taken to achieve complete wound closure
Time frame: 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
Occurrence of infection during study period
Time frame: Up to 12 weeks post-intervention
Occurrence of further minor amputation during study period
Time frame: Up to 12 weeks post-intervention
Occurrence of major amputation during study period
Time frame: Up to 12 weeks post-intervention
Occurrence of death during study period
Time frame: Up to 12 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Background: PubMed 36240798Ciprandi G, Kjartansson H, Grussu F, Baldursson BT, Frattaroli J, Urbani U, Zama M. Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. J Wound Care. 2022 Oct 2;31(10):824-831. doi: 10.12968/jowc.2022.31.10.824.
- Background: PubMed 22561521Aerden D, Vanmierlo B, Denecker N, Brasseur L, Keymeulen B, Van den Brande P. Primary closure with a filleted hallux flap after transmetatarsal amputation of the big toe for osteomyelitis in the diabetic foot: a short series of four cases. Int J Low Extrem Wounds. 2012 Jun;11(2):80-4. doi: 10.1177/1534734612446640. Epub 2012 May 4.
- Background: PubMed 11818842Blume PA, Paragas LK, Sumpio BE, Attinger CE. Single-stage surgical treatment of noninfected diabetic foot ulcers. Plast Reconstr Surg. 2002 Feb;109(2):601-9. doi: 10.1097/00006534-200202000-00029.
- Background: PubMed 16890866Berceli SA, Brown JE, Irwin PB, Ozaki CK. Clinical outcomes after closed, staged, and open forefoot amputations. J Vasc Surg. 2006 Aug;44(2):347-351; discussion 352. doi: 10.1016/j.jvs.2006.04.043.
- Background: PubMed 33344649Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.
- Background: PubMed 34526864Normandin S, Safran T, Winocour S, Chu CK, Vorstenbosch J, Murphy AM, Davison PG. Negative Pressure Wound Therapy: Mechanism of Action and Clinical Applications. Semin Plast Surg. 2021 Aug;35(3):164-170. doi: 10.1055/s-0041-1731792. Epub 2021 Sep 10.
- Background: PubMed 34916107Riandini T, Pang D, Toh MPHS, Tan CS, Choong AMTL, Lo ZJ, Chandrasekar S, Tai ES, Tan KB, Venkataraman K. National Rates of Lower Extremity Amputation in People With and Without Diabetes in a Multi-Ethnic Asian Population: a Ten Year Study in Singapore. Eur J Vasc Endovasc Surg. 2022 Jan;63(1):147-155. doi: 10.1016/j.ejvs.2021.09.041. Epub 2021 Dec 14.
- NPWT in closed foot woundsLink provided by the sponsor.
- NPWT in closed foot woundsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Due to Personal Data Protection Act.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jack Kian Ch'ng principal investigator
Singapore General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy, Kerecis and Delayed primary closure with local flap in people with Diabetic Foot Ulcer, run by Singapore General Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charyl Yap, B.Sc (+65 6576 7986, charyl.yap.j.q@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 100% Wound Closure at 12 weeks (time frame: 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832787, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.