NCT01396837

Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

A Multi-Center, Prospective, Open Label Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: RedDress Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety of the RedDress Wound Care System (RD1) in patients Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.

Detailed description

The investigational product, the RD1 kit, was designed to enable a care provider to create an in vitro blood clot from the patient's own blood at the point of care, in a safe and effective manner. While many advanced modalities of treatment have been developed to heal chronic DFUs (as well as other types of chronic wounds), the vast majority have been approved for relatively non-severe wounds (e.g., Texas 1a/2a grades) and relatively healthy subjects in controlled clinical trials and typically exclude 25-75% of subjects who have several comorbidities and severe wounds. Moreover, when the results of such trials (and other trials of advanced modalities) have been subject to a systematic review, the strength of the evidence for their efficacy has been rated low or even insufficient to judge. Consequently, there is an urgent need for new technologies to be tested that can improve healing rates in all classes of chronic DFUs. The study is a multi-center, prospective, single group safety study, consisting of 20 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects). The subjects will receive 12 weekly RD1 applications. Subject data will be kept in each site's records.

Conditions

• Neuropathic Diabetic Ulcer - Foot

Interventions

Type	Name	Description
DEVICE	RedDress Wound Care System (RD1)	Weekly application. A blood based wound care treatment

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-08-01
• Completion: 2017-03-01
• First posted: 2011-07-19
• Last updated: 2020-12-02
• Results posted: 2020-11-16

Locations

4 sites across 1 country: United States