U.S., June 30 -- ClinicalTrials.gov registry received information related to the study (NCT07674420) titled 'Wearable Insoles for Recurrent Diabetic Ulcer Prevention' on June 23.
Brief Summary: The primary objective of the study is to demonstrate the clinical advantages of using the Orpyx SI Sensory Insole (SI) system as an adjunct to standard of care, as compared to standard of care alone, in reducing plantar ulceration in high-risk individuals. The investigators aim to understand participant quality of life, the economic impact and cost-effectiveness of the Orpyx SI insole system, and to evaluate participant engagement and compliance.
Study Start Date: Oct. 17, 2023
Study Type: INTERVENTIONAL
Condition:
Diabetes
Peripheral Neuropathy...