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

NCT01396837 | Completed Phase 2 Results

• 1 other identifier: RD003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Neuropathic Diabetic Ulcer - Foot

Keywords

Diabetic Foot Ulcer; Diabetic Ulcer; Diabetic Wound; Chronic Ulcer; Chronic Wound; Neuropathic Diabetic Foot Ulcer; Neuropathic DFU; DFU

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events

  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).

  12 weeks

Secondary Outcomes (3)

• Number of Participants Experience Complications Due to Lack of Venous Access

  12 weeks

• Number of Participants Achieving a Complete Wound Closure at 12 Weeks

  12 weeks

• Percent of Reduction in Wound Size Over 12 Weeks (ITT Population)

  12 weeks

Study Arms (1)

RedDress Wound Care System (RD1)

EXPERIMENTAL

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)

Interventions

RedDress Wound Care System (RD1) DEVICE

Weekly application. A blood based wound care treatment

Also known as: RedDress Wound Care System, RD1

RedDress Wound Care System (RD1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥18 years of age and has type 1 or 2 diabetes
• Texas grade 1a or 2a wound located distal to the malleolus (excluding ulcers between the toes but including those of the heel) and depth ≤ 5 mm with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts
• For patients with potentially multiple eligible DFUs, the biggest ulcer will be chosen as the study ulcer.
• Ulcer size between 1 cm2 and 12 cm2 (post-debridement).
• Study ulcer separated from other ulcers by at least 2 cm.
• Ulcer or affected limb free of clinical signs of infection. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection).
• Post-debridement, ulcer free of necrotic tissue.
• Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following: (a) Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2; (b) toe pressure (plethysmography) \> 50 mm Hg; (c) TcPO2 \> 40 mm Hg; or (d) skin perfusion pressure (SPP) \> 30 mm Hg.
• HbA1c ≤ 12.0% (diabetic patients)
• Demonstrated adequate offloading regimen.
• Subject must be willing to comply with the protocol including having blood drawn to create the RD1.
• Female subjects who are capable of conceiving and all males capable of insemination 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).

You may not qualify if:

• Ulcer not of neuropathic diabetic foot pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or pressure ulcers.).
• Presence of 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.
• 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 randomization 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, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the past 12 months, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
• Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) 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 12 months.
• Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.
• Cannot withdraw blood in the required amount (up to 10 mL per week) technically.
• Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) will not be excluded.
• Hemoglobin anemia (\< 10 g/dL).
• Subject has a history of or any of the following intercurrent illnesses or conditions that would compromise the safety of the subject, or the normal wound healing process:
• End stage renal disease

Sponsors & Collaborators

• RedDress Ltd.: lead

Study Sites (4)

Amun Research

Miami, Florida, 33185, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

SerenaGroup Research Institute

Pittsburgh, Pennsylvania, 15222, United States

Location

Martin Foot and Ankle

York, Pennsylvania, 17402, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Saron Sirota, Clinical Team Leader
• Organization: RedDress

sharon@reddress.co.il

+972-54-5800765

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Autologous Blood Clot Product was applied to all patients

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 19, 2011
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: March 1, 2017
• Last Updated: December 2, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-11

Locations

US (4)