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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01396837
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : April 17, 2017
Information provided by (Responsible Party):
RedDress Ltd.

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.

Condition or disease Intervention/treatment Phase
Neuropathic Diabetic Ulcer - Foot Device: RedDress Wound Care System (RD1) Phase 2

Detailed Description:

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 multi-center, 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safety study, consisting of 20 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss of these subjects).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 12 weekly RD1 applications. Subject data will be kept in each site's records.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Open Label Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
Actual Study Start Date : May 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other Names:
  • RedDress Wound Care System
  • RD1

Primary Outcome Measures :
  1. Adverse event rate [ Time Frame: 12 weeks ]
    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).

Secondary Outcome Measures :
  1. Complication rate due to lack of venous access [ Time Frame: 12 weeks ]
    for all patients for all 12 visits involving RD1 procedure (ITT population)

  2. Complication rate due to lack of venous access [ Time Frame: 12 ]
    for all patients for all 12 visits involving other procedure requiring venous access (ITT population)

  3. Incidence of complete wound closure at 12 weeks [ Time Frame: 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).

  4. Percent reduction in wound size over 12 weeks (ITT population) [ Time Frame: 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

  5. Associations between lack of healing and patient/wound parameters (ITT population) [ Time Frame: 2 years ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Prior to inclusion of an ulcer in the study, each wound will be reviewed for eligibility by an independent assessor using a central online review process that includes images of the ulcer.
  • 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).
  • Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until day 0.
  • 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).

Exclusion Criteria:

  • 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
    • Immunosuppression.
    • Severe malnutrition
    • Liver disease
    • Scleroderma
    • Acquired immune deficiency disease (AIDS) or HIV positive
    • Connective tissue disorder
    • Exacerbation of sickle cell anemia
  • 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%, subject will be excluded.
  • Women who are pregnant or currently breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396837

United States, Florida
Amun Research
Miami, Florida, United States, 33185
Barry University Clinical Research
North Miami Beach, Florida, United States, 33169
United States, Pennsylvania
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, United States, 15222
Martin Foot and Ankle
York, Pennsylvania, United States, 17402
Sponsors and Collaborators
RedDress Ltd.

Responsible Party: RedDress Ltd. Identifier: NCT01396837     History of Changes
Other Study ID Numbers: RD003
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017

Keywords provided by RedDress Ltd.:
Diabetic Foot Ulcer
Diabetic Ulcer
Diabetic Wound
Chronic Ulcer
Chronic Wound
Neuropathic Diabetic Foot Ulcer
Neuropathic DFU

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases