Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPost Graduate Institute of Medical Education and Research, Chandigarh

About this trial

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.

Eligibility criteria

Qualifiers

Type 2 Diabetes Mellitus

Unilateral pedal swelling

Active Charcot Neuroarthropathy

Age: 18 years and above.

Disqualifiers

presence of pedal ulcer,

osteoporosis (T score <-2.5 at lumbar spine or hip),

gout,

active peptic ulcer disease,

Trial design

Treatments tested in this trial

  • Total Contact Cast
  • Posterior Slab

Treatment groups

80 Participants
are divided into 2 treatment groups