Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jan 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of specially designed silicone orthotic devices, which are like custom-made shoe inserts, on people with diabetic neuropathy. Diabetic neuropathy is a condition that can cause numbness and pain in the feet, making individuals more vulnerable to foot problems, including ulcers and deformities. The trial aims to see if these orthoses can help improve foot health, reduce the risk of foot ulcers, and enhance the overall quality of life for participants over six months.

To participate in this study, individuals need to be between 65 and 74 years old and have either type 1 or type 2 diabetes along with confirmed diabetic nerve damage. They should also have at least one foot deformity, such as claw toes or bunions, and be able to walk independently. Participants will not be accepted if they have certain other health issues, like major blood vessel problems or dementia. If eligible, participants can expect to wear the customized orthoses and have regular check-ups to monitor their foot health throughout the study. This trial is an important opportunity to find better solutions for managing foot care in people with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g Semmes-Weinstein monofilament or 128Hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy);
• • Presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad);
• • Ability to walk independently with or without the aid of a walking device;
• Exclusion Criteria:
• • Presence of other diagnosed neurological diseases;
• • Presence of dementia or inability to give consistent information;
• • Presence of major vascular complications;
• • Receiving any physiotherapy intervention;
• • Major vascular complications (ischemia)
• • Presence of an active ulcer at the time of baseline assessment;
• • Major amputations;
• • Minor amputations, except toes.