Using Negative Pressure Wound Therapy for Healing Diabetic Foot Wounds
Official title: Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds
Run by Singapore General Hospital · NCT06832787 · Data updated 2026-11-12
This study tests if using Negative Pressure Wound Therapy along with skin substitutes can help heal diabetic foot wounds better for people who have had toe amputations.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 100 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT06832787 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21-100 who have undergone first or last toe ray amputations and have adequate perfusion.
✕Probably not a fit
Patients with amputations not at the first or last toe, venous ulcers, heel ulcers, osteomyelitis, active infections, or those on immunosuppressants may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Negative Pressure Wound Therapy (NPWT) in combination with dermal substitutes for treating diabetic foot ulcers. Given the high rates of diabetes-related amputations in Singapore, the study aims to improve wound healing and reduce infection risks associated with these ulcers. Participants will receive NPWT and may undergo delayed primary closure with a local flap if necessary. The study focuses on patients who have experienced toe ray amputations and have adequate blood flow to the affected area.
Why it matters
Potential benefit: If successful, this approach could significantly enhance wound healing and reduce the need for amputations in diabetic patients.
How similar studies have gone: Other studies have shown positive outcomes with Negative Pressure Wound Therapy in similar contexts, indicating a promising approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Singapore General Hospital
Singapore, Singapore Recruiting -
Sengkang General Hospital
Singapore, Singapore Recruiting
Study contacts
- Principal investigator: Jack Kian Ch'ng — Singapore General Hospital
- Study coordinator: Charyl Yap, B.Sc
- Email: charyl.yap.j.q@sgh.com.sg
- Phone: +65 6576 7986
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BIOxHEAL plus standard care for nonhealing diabetic foot ulcers
A multicenter study tests whether applying BIOxHEAL, a placental-derived biologic, to stubborn diabetic foot ulcers helps more people heal when added to standard wound care.
-
Calcaneal Bone Marrow Cells in Foot/Ankle Surgery Patients
This observational study tests whether routine preoperative blood tests relate to the quality and behavior of mesenchymal stem cells from calcaneal bone marrow in adults undergoing foot or ankle surgery.
-
L-Carnitine as an add-on for healing diabetic foot ulcers
This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.
-
THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers
This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.
-
Pulsating electromagnetic field therapy for diabetic foot ulcers
This trial tests whether a PEMF device called CRAD ULCER X-01 helps heal chronic diabetic foot ulcers when added to standard wound care.
-
Transverse tibial bone transport to help heal chronic diabetic foot ulcers
This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.