Neuropathic Diabetic Ulcer - FootPhase 2NCT01396837
Safety Trial of the RedDress Wound Care System (RD1) in Management of Texas 1a or 2a Neuropathic Diabetic Foot Ulcers.
A Phase 2 study testing RedDress Wound Care System (RD1) in people with Neuropathic Diabetic Ulcer - Foot, run by RedDress Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Diabetic Ulcer - Foot
- What is being tested?
- RedDress Wound Care System (RD1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Amun Research
Miami, Florida, 33185
Barry University Clinical Research
North Miami Beach, Florida, 33169
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
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.
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.
Read the 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.
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Being tested
- RedDress Wound Care System (RD1)
- Keywords
- Diabetic Foot Ulcer, Diabetic Ulcer, Diabetic Wound, Chronic Ulcer, Chronic Wound, Neuropathic Diabetic Foot Ulcer, Neuropathic DFU, DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RedDress Wound Care System (RD1)Device
Also called RedDress Wound Care System, RD1
Weekly application. A blood based wound care treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: RedDress Wound Care System (RD1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (3)
Number of Participants Experience Complications Due to Lack of Venous Access
For all patients for all 12 visits involving RD1 procedure (ITT population)
Measured: 12 weeks
Number of Participants Achieving a Complete Wound Closure at 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).
Measured: 12 weeks
Percent of Reduction in Wound Size Over 12 Weeks (ITT Population)
The data will also be plotted graphically week by week. Week 12 data will be used to recalculate sample size for the pivotal trial
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuropathic Diabetic Ulcer - FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Autologous Blood Clot Product was applied to all patients
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396837
- Sponsor's protocol ID
- RD003
- Status last verified
- Nov 2020
- First submitted
- 5 Jul 2011
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01396837
- Acronym / sponsor ID
- RD003
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Keywords
- Diabetic Foot Ulcer, Diabetic Ulcer, Diabetic Wound, Chronic Ulcer, Chronic Wound, Neuropathic Diabetic Foot Ulcer, Neuropathic DFU, DFU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Autologous Blood Clot Product was applied to all patients
| Arm | Type | Receives |
|---|---|---|
| RedDress Wound Care System (RD1) | Experimental | Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RedDress Wound Care System (RD1)Also: RedDress Wound Care System, RD1Weekly application. A blood based wound care treatment | Device | RedDress Wound Care System (RD1) |
Primary outcome
Number of Participants Experiencing Adverse Events
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).
3 secondary outcomes
Number of Participants Experience Complications Due to Lack of Venous Access
Time frame: 12 weeks
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Time frame: 12 weeks
Percent of Reduction in Wound Size Over 12 Weeks (ITT Population)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RedDress Wound Care System (RD1) in people with Neuropathic Diabetic Ulcer - Foot, run by RedDress Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.