Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

NCT06573554 | Recruiting DMC

• 1 other identifier: OFFLOAD STUDY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot. The study compares two treatments: a standard knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker. Both aim to immobilize and offload the foot to promote healing. The study will involve diabetic patients with specific criteria and exclude those with conditions like foot ulcers or severe kidney issues. Patients will be randomly assigned to one of the two treatments and followed for up to a year. The primary goal is to see how many patients achieve remission within six months, with secondary goals including remission within twelve months, time to remission, quality of life, and foot health. Statistical tests will be used to analyze the data and determine the effectiveness of each treatment. The study aims to improve CN treatment and provide better options for patients.

Conditions

Charcot Neuroarthropathy

Keywords

Charcot Neuroarthropathy; Total Contact Cast; Diabetic Foot; Posterior Slab; Vibration Perception Threshold; Peripheral Neuropathy; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Efficacy of posterior Slab

  Proportion of participants achieving active CNO remission with Posterior slab compared to Total contact Cast

  26 weeks

Secondary Outcomes (3)

• Proportion of participants achieving remission 48 weeks

  48 weeks

• Time to achieve remission

  48 weeks

• Life Quality 1

  48 weeks

Study Arms (2)

Total Contact Cast (TCC) Comparator Arm

ACTIVE COMPARATOR

standardised non-walking, non-removable, knee high, fibre-glass total contact cast

Device: Total Contact Cast

Posterior Slab Comparator Arm

ACTIVE COMPARATOR

posterior non-removable knee high slab

Device: Posterior Slab

Interventions

Total Contact Cast DEVICE

Knee High Fiber Glass Total contact Cast

Total Contact Cast (TCC) Comparator Arm

Posterior Slab DEVICE

Posterior Slab Knee high non walking

Posterior Slab Comparator Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus
• Unilateral pedal swelling
• Active Charcot Neuroarthropathy
• Age: 18 years and above.
• Ability to Provide Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Department of Endocrinology, PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Peripheral Nervous System Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ashu Rastogi, DM MD

  PGIMER, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashu Rastogi, DM MD

CONTACT

9781001046; rastogi.ashu@pgi.ac.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators including radiologist interpretation x ray and MRI shall be blinded to treatment allocation. Also one of the investigator as outcome assessor shall be blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 1:1 randomization

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 27, 2024
• Study Start: December 11, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)