Efficacy of Teriparatide in Diabetic Inactive Charcot Neuroarthropathy of Foot

What Was Tested

The trial (phase 2) is built around Teriparatide.

It had two arms (groups): teriparatide (active comparator) and placebo (placebo comparator).

10 diabetic patients with inactive Charcot's foot who are calcium and Vit.D sufficient will receive placebo , subcutaneous between 8-9 p.m. , daily.

The registry classes the interventions as drug and other.

More on the Plan

Charcot neuroarthropathy (CN) was first described by Jean-Martin Charcot in a patient with tabes dorsalis who recognized that peripheral neuropathy could lead to neuropathic joints.

This condition has many names, including Charcot osteoarthropathy, neuropathic osteo- arthropathy, and many others.

Charcot foot may occur as a complication of neurosyphilis, syringomyelia, leprosy, poliomyelitis, congenital neuropathy and diabetes mellitus , the latter currently being the most common cause of CN.

Since the description of CN in 1883, its pathophysiology remains an enigma, and there are no strict guidelines for the treatment of this disorder.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: No warmth or redness of foot. Difference in temperature between two foot \< 2 degree Centigrade. If deformity present , patient able to walk without aid. History of resolved active Charcot's neuroarthropathy of foot. Radiological criteria: Plain X-ray foot (weight bearing lateral and oblique) showing at least 3 of the following features -.

The full record lists 12 inclusion and 15 exclusion criteria; among the exclusions: active inflammatory phase of charcot's neuroarthropathy; active on inactive charcot's neuroarthropathy; osteomyelitis of foot bones.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Teriparatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Teriparatide.

Those kept unaware of assignments: participant and care provider.

It started in 2014-01 with completion listed for 2018-12.

It ran at 2 sites in India (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: SUV Max on PET/CT Scan at 12 Months (time frame: 12 months).

It also tracked 1 secondary outcome, for example Clinical Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teriparatide compound page, all human trials.