Trial Outcomes & Findings for A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1 (NCT NCT04577183)

NCT ID: NCT04577183

Last Updated: 2024-12-02

Results Overview

Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2024-12-02

Participant Flow

Participant milestones

Measure	RD1 System The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
Overall Study STARTED	13
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	RD1 System The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
Overall Study Death	1
Overall Study Withdrawal by Subject	3
Overall Study Early termination	2

Baseline Characteristics

A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1

Baseline characteristics by cohort

Measure	RD1 System n=13 Participants The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Number of patients showed Percent of wound reduction in the intent to treat (ITT) population

Numer of patients showed Percent of wound reduction from baseline to end of treatment in the intent to treat (ITT) population

Outcome measures

Measure

RD1 System n=13 Participants The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.

Number of Participants With Reduction in Wound Size

7 participants with Wound Size reduction

Adverse Events

RD1 System

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure

RD1 System n=13 participants at risk The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.

Cardiac disorders Death

7.7% 1/13 • Number of events 1 • 16 weeks

Other adverse events

Measure	RD1 System n=13 participants at risk The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings. RD1 System: The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
Musculoskeletal and connective tissue disorders Multiple fluid filled blisters to left lower extrimity	7.7% 1/13 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Open area on right upper shin	7.7% 1/13 • Number of events 1 • 16 weeks
Musculoskeletal and connective tissue disorders Cellulitis	7.7% 1/13 • Number of events 1 • 16 weeks
General disorders Fever	7.7% 1/13 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders Skin tear	7.7% 1/13 • Number of events 5 • 16 weeks
Skin and subcutaneous tissue disorders New ulcer	7.7% 1/13 • Number of events 2 • 16 weeks
Infections and infestations Infection to study ulcer	7.7% 1/13 • Number of events 1 • 16 weeks

Additional Information

Clinical Trial Manager

RedDress Medical

Phone: 1-800-674-9615

Email: alon@reddress.co.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place