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 ID: NCT04577183

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-02-01

Brief Summary

The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects).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 up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records.

All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care

Conditions

Diabetic Foot Ulcer; Pressure Ulcer; Venous Leg Ulcer; Trauma Injury; Skin Tear; Chronic Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RD1 System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject is ≥18 years of age
• Patient with a wound deemed suitable for treatment with RD1
• Ulcer free of clinical signs of infection.
• Post-debridement, ulcer free of necrotic tissue.
• For foot ulcers, Subject has adequate vascular perfusion of the affected limb, as defined by - Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2
• HbA1c ≤ 12.0% (diabetic patients)
• Subject or legal authorized representative must be willing to comply with the protocol including having blood drawn to create the RD1.
• Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).

Exclusion Criteria

• If ulcer area decreases by ≥ 30% during the initial 2-week screening (± 2 days) and standard of care phase, or if the ulcer area increases ≥ 30%,
• Presence of active underlying osteomyelitis.
• Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection
• Known malignancy in the reference wound bed or margins of the wound
• Exposure of blood vessels or organs at the base of the reference wound
• History of alcohol or substance abuse, within the previous 2 months
• Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug or treatment within 30 days of day 0 visit.
• Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with, or affect the rate and quality of, wound healing (e.g., systemic steroids (more than 10mg per day), immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the ulcer area, vascular surgery, angioplasty or thrombolysis).
• Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of randomization or is scheduled to receive during the study.
• Subject has been treated with hyperbaric oxygen within 5 days of screening or is scheduled to receive during the study.
• Wound on a patient who has a life expectancy of less than 6 months.
• Cannot withdraw blood in the required amount technically.
• Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking orally Coumadin, Aspirin, or Plavix (clopidogrel) will not be excluded.
• Hemoglobin anemia (< 9 g/dL).
• Subject has an infectious disease, such as Acquired Immune Deficiency Disease (AIDS) or HIV, Hepatitis C, Hepatitis B, Human T-lymphotropic virus or Syphilis
• Women who are pregnant or currently breast feeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RedDress Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sunnyview Nursing & Rehabilitation Center

Butler, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

RD004

Identifier Type: -

Identifier Source: org_study_id