Using Negative Pressure Wound Therapy for Healing Diabetic Foot Wounds
Prospective, Multi-Center Randomized Controlled Trial for the Combinational Use of Negative Pressure Wound Therapy (NPWT) for the Treatment of Diabetic Wounds
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 100 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06832787 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-100 who have undergone first or last toe ray amputations and have adequate perfusion.
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.
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 performed: Other studies have shown positive outcomes with Negative Pressure Wound Therapy in similar contexts, indicating a promising approach.
Eligibility criteria
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 this trial is running
Singapore and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.