A Prospective, Open Label Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
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.
Neuropathic Diabetic Ulcer - Foot
Device: RedDress Wound Care System (RD1)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open Label Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.|
- Adverse event rate [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]Adverse event rate will be calculated including serious adverse events (SAEs), adverse events (AEs) (including any lack of venous access events), and device-related adverse events (DRAEs) (safety population and ITT populations).
- Complication rate due to lack of venous access [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]for all patients for all 10 visits involving RD1 procedure (ITT population)
- Complication rate due to lack of venous access [ Time Frame: 10 ] [ Designated as safety issue: Yes ]for all patients for all 10 visits involving other procedure requiring venous access (ITT population)
- Incidence of complete wound closure at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart) for DFU treated with RD1 (ITT population).
- Percent reduction in wound size over 12 weeks (ITT population) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The data will also be plotted graphically week by week. Week 12 data will be used to recalculate sample size for the pivotal trial
- Associations between lack of healing and patient/wound parameters (ITT population) [ Time Frame: 2 years ] [ Designated as safety issue: No ]A simple Cox regression will be used to examine each wound and patient parameter. Note: because sample size is very small, a full Cox regression cannot be undertaken.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: RedDress Wound Care System (RD1)
RD1 is a biologic autologous wound care product which is comprised of the patient whole blood and produced in the point of care using the RD1 kit
Device: RedDress Wound Care System (RD1)
Weekly application. A blood based wound care treatment
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 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 10 weekly RD1 applications and will be followed for additional 2 weeks. If the wound heal on weeks 11-12, additional 2 weeks follow up will be required. Subject data will be kept in each site's records.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396837
|United States, Pennsylvania|
|ACMH Hospital - Snyder Institute for Vascular Health and Research||Recruiting|
|Kittanning, Pennsylvania, United States, 16201|
|Contact: Serena 724-543-8893|
|Principal Investigator: Dr. Keyur Patel, DO|