NCT04332003

Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care

A Randomized Controlled Double-Blind Multi-Center Clinical Trial Evaluating Remote Ischemic Conditioning (RIC) and Standard of Care vs. Sham Therapy and Standard Care in the Healing of Diabetic Foot Ulcers

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A double blind, randomized controlled clinical trial comparing wound closure rates of diabetic foot ulcers (DFUs) in subjects receiving active RIC treatment plus standard of care compared to those receiving sham treatment plus standard of care.

Detailed description

The general objective of this double-blind study is to test the effectiveness of RIC in a population of patients with diabetic foot ulcers: Active treatment 3x per week (RIC) plus SOC compared to Sham Comparator 3x per week and SOC Determine median time to initial wound closure in both active and sham group.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Remote Ischemic Conditioning (RIC) Treatment	RIC treatment will be delivered by an automated device that delivers the RIC treatment (manufactured by LifeCuff Technologies).

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-02-06
• Completion: 2021-02-06
• First posted: 2020-04-02
• Last updated: 2021-02-15

Regulatory

• FDA-regulated device study