Trial Outcomes & Findings for Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers. (NCT NCT01396837)

Last Updated: 2020-12-02

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RedDress Wound Care System (RD1) n=20 Participants 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Age, Customized >18 year	20 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT population

Outcome measures

Outcome measures
Measure	RedDress Wound Care System (RD1) n=20 Participants 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Number of Participants Experiencing Adverse Events	20 Participants

SECONDARY outcome

Timeframe: 12 weeks

For all patients for all 12 visits involving RD1 procedure (ITT population)

Outcome measures

Outcome measures
Measure	RedDress Wound Care System (RD1) n=20 Participants 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Number of Participants Experience Complications Due to Lack of Venous Access	0 Participants

SECONDARY outcome

Timeframe: 12 weeks

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).

Outcome measures

Outcome measures
Measure	RedDress Wound Care System (RD1) n=20 Participants 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Number of Participants Achieving a Complete Wound Closure at 12 Weeks	13 Participants

SECONDARY outcome

Timeframe: 12 weeks

The data will also be plotted graphically week by week. Week 12 data will be used to recalculate sample size for the pivotal trial

Outcome measures

Outcome measures
Measure	RedDress Wound Care System (RD1) n=20 Participants 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Percent of Reduction in Wound Size Over 12 Weeks (ITT Population)	67.1 percentage of area reduction Interval 34.2 to 100.0

Adverse Events

RedDress Wound Care System (RD1)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RedDress Wound Care System (RD1) n=20 participants at risk 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Blood and lymphatic system disorders Embolism	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Infections and infestations Infection,	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Psychiatric disorders Psychiatric issue	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events

Other adverse events

Other adverse events
Measure	RedDress Wound Care System (RD1) n=20 participants at risk 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 RedDress Wound Care System (RD1): Weekly application. A blood based wound care treatment
Blood and lymphatic system disorders Embolism	5.0% 1/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Gastrointestinal disorders Gastrointestinal problem	10.0% 2/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Infections and infestations Infection, Other	10.0% 2/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Musculoskeletal and connective tissue disorders New DFU	30.0% 6/20 • Number of events 6 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Musculoskeletal and connective tissue disorders Gout	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Injury, poisoning and procedural complications Pain at study ulcer	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Injury, poisoning and procedural complications Friction blister at study ulcer	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Injury, poisoning and procedural complications Friction blister, other wound	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Infections and infestations Prophylactic use antibiotics	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Psychiatric disorders Psychiatric issue	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Skin and subcutaneous tissue disorders Rash	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Musculoskeletal and connective tissue disorders Restless leg syndrome	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Musculoskeletal and connective tissue disorders Sudden increase area study ulcer	10.0% 2/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Injury, poisoning and procedural complications Traumatic injury (not study wound)	10.0% 2/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Injury, poisoning and procedural complications Traumatic injury (study wound)	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Renal and urinary disorders Urinary tract infection	5.0% 1/20 • Number of events 1 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Infections and infestations Infection, other wound	10.0% 2/20 • Number of events 2 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events
Infections and infestations Infection, study DFU	20.0% 4/20 • Number of events 4 • Subjects were followed for 12 weeks The NCI CTCAEv5 scale was used to grade adverse events/serious adverse events

Additional Information

Saron Sirota, Clinical Team Leader

RedDress

Phone: +972-54-5800765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place