Comparing two methods for treating Charcot neuroarthropathy in diabetic patients
Official title: Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy of Foot in Diabetes (OFFLOAD Study): A Multicentric, Non-inferiority Study
Run by Post Graduate Institute of Medical Education and Research, Chandigarh · NCT06573554 · Data updated 2026-11-12
This study is testing which of two treatments, a total contact cast or a posterior slab, works better to help diabetic patients with Charcot neuroarthropathy heal their feet.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh) |
| Status | Recruiting |
| Started | December 11, 2024 |
| Main results expected | October 30, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | January 22, 2025 |
| Trial ID | NCT06573554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with type 2 diabetes and unilateral active Charcot neuroarthropathy.
✕Probably not a fit
Patients with foot ulcers, severe kidney issues, or other specified exclusion criteria 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 two offloading treatments for Charcot neuroarthropathy in diabetic patients: a total contact cast (TCC) and a posterior slab. Patients with active Charcot neuroarthropathy will be randomly assigned to receive one of the two treatments, which aim to immobilize and relieve pressure on the affected foot to promote healing. The primary outcome is the rate of remission within six months, while secondary outcomes include quality of life and overall foot health over a year. The study will utilize statistical analysis to compare the effectiveness of both interventions.
Why it matters
Potential benefit: If successful, this study could provide improved treatment options for diabetic patients suffering from Charcot neuroarthropathy.
How similar studies have gone: While the treatment of Charcot neuroarthropathy has been explored, this specific comparison of TCC and posterior slab is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 Diabetes Mellitus * Unilateral pedal swelling * Active Charcot Neuroarthropathy * Age: 18 years and above. * Ability to Provide Consent Exclusion Criteria: * presence of pedal ulcer, * osteoporosis (T score \<-2.5 at lumbar spine or hip), * gout, * active peptic ulcer disease, * steroid intake in the last three months, * estimated glomerular filtration rate (eGFR) \<30 ml/min/m2, * active dental caries or invasive dental procedure, * peripheral vascular disease (ABI \< 0.7), * bilateral foot involvement, * pregnant/ lactating women and * those who had recently received antiresorptive agents (in the previous 12 months). * Negative consent
Where it's running
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Department of Endocrinology, PGIMER
Chandigarh, India Recruiting
Study contacts
- Principal investigator: Ashu Rastogi, DM MD — PGIMER, India
- Study coordinator: Ashu Rastogi, DM MD
- Email: rastogi.ashu@pgi.ac.in
- Phone: 9781001046
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.