Critical Limb IschemiaNCT02046226
Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A study testing Oxygenesys(TM) Dissolved Oxygen Dressing in people with Critical Limb Ischemia, run by Halyard Health at 1 site in United States.
Trial summary
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to May 2014
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female >=21 years of age
- A clinical diagnosis of critical limb ischemia (CLI) with Rutherford classification stage 5
- One or more chronic ulcers with a presumed etiology of arterial insufficiency and duration >2 weeks. The target ulcer is defined as the highest-grade ulcer (Wagner's classification) at initial evaluation. For wounds with identical grading, the largest wound is the index wound
- The patient or legally authorized representative is willing to provide informed consent and comply with specified follow-up evaluations
- Undergoing intervention for infrainguinal or infrapopliteal artery disease (below the femoral artery bifurcation and above the ankle joint)
- The index procedure resulted in successful revascularization. For endovascular procedures, successful revascularization is defined as complete revascularization of the target ulcer culprit vessels according to the angiosome treatment strategy, with a final percent diameter stenosis >50% and improved distal flow by angiography following the procedure. For surgical procedures, successful revascularization is defined as a patent graft and improved distal flow following the procedure.
Who cannot join
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure.
- Rutherford classification stage 0,1,2,3,4, or 6
- Target wound duration <2 weeks
- Presence of frank gangrene (Wagner classification grade 4 or 5), major tissue loss (severe/extensive necrosis), or unsalvageable limb (extensive ischemic ulceration beyond the transmetatarsal level anticipated to require major amputation after the index procedure)
- Previous or planned surgical or interventional procedure within 6 months before or 30 days after the index procedure, or any previous or planned target limb amputation.
- Active local or systemic infection
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- Patients with ulcers judged by the examining physician to have a primary etiology other than ischemic arterial disease (e.g., venous related, decubitus, or other [goug, pyoderma gangrenosum, necrobiosis lipoidica, vitamin B12 deficiency])
- Renal failure or chronic kidney disease with estimated glomerular filtration rate (eGFR <30 ml/min/1.7sm sq. within 30 days of the index procedure or treated with dialysis)
- Severly decreased cardiac output
- Uncontrolled hyperglycemia
- Patients with a known other medical illness or known history of substance abuse that may cause non-compliance with the protocol, confound data interpretation, or is associated with a life expectancy of less than 1 year
- Patient is currently participating (or has participated in the last 30 days) in a study of any other investigational treatment.
- Ulcer treatment with normothermic or hyperbaric oxygen therapy, recombinant or autologous growth factor products, or use of enzymatic debridement
- Concomitant medications such as corticosteroids, immunosuppressive medications, or chemotherapy
- Acute thrombus in the target limb
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: A Prospective, Randomized, Single-center Pilot Study of the OxyGenesys™ Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
Read the detailed description
A Prospective, Randomized, controlled pilot study enrolling up to 50 subjects at a singe investigational site in the US. Subjects with atherosclerotic peripheral arteria disease (PAD) presenting with critical limb ischemia (CLI) and one or more non-healing lower extremity arterial insufficiency ulcers who are suitable candidates for revascularization procedures (endovascular or surgical) will be randomized 1:1 to:
- Wound care with the use of OxyGenesys(TM) Dissolved Oxygen Dressing, or
- Standard Wound Care procedures
An initial study phase will enroll up to 20 subjects (10 in each arm). Pending results of the initial study phase, the study may continue to enroll until up to 50 subjects (25 in each arm) have been enrolled.
All subjects will be followed clinically and receive wound evaluation at 1, 3, and 6 months.
- Conditions
- Critical Limb Ischemia
- Being tested
- Oxygenesys(TM) Dissolved Oxygen Dressing
- Keywords
- Critical Limb Ischemia, Non Healing Wounds, Diabetic Wounds, Foot Ulcers
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygenesys(TM) Dissolved Oxygen DressingDevice
OxyGenesys(TM) Dissolved Oxygen Dressing
| Study group | Role | What they receive |
|---|---|---|
| OxyGenesys(TM) Dissolved Oxygen Dressing | Experimental | OxyGenesys(TM) Dissolved Oxygen Dressing Receives: Device: Oxygenesys(TM) Dissolved Oxygen Dressing |
| Standard Wound Care | No intervention | Standard wound care using gauze dressings per institutional standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Wound Healing
Percentage reduction in target wound area (length x width).
Measured: 3 months
Secondary outcomes (1)
Incidence of Complete Wound Closure
number of wounds undergoing complete reepithelialization without drainage or dressing requirements, maintained for at least 2 weeks.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: inability to meet enrollment goals in this subject population
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 Critical Limb IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Carlos Mena-Hurtado, MD, Principal investigator, Yale UniversityDavid T Curd, MS, Study director, Kimberly-Clark Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046226
- Sponsor's protocol ID
- 100-13-0001
- Status last verified
- Nov 2014
- First submitted
- 23 Jan 2014
- Last updated
- 12 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-center Pilot Study of the OxyGenesys™ Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02046226
- Acronym / sponsor ID
- 100-13-0001
- Conditions
- Critical Limb Ischemia
- Keywords
- Critical Limb Ischemia, Non Healing Wounds, Diabetic Wounds, Foot Ulcers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to meet enrollment goals in this subject population
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Posted 12 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.
Detailed description
A Prospective, Randomized, controlled pilot study enrolling up to 50 subjects at a singe investigational site in the US. Subjects with atherosclerotic peripheral arteria disease (PAD) presenting with critical limb ischemia (CLI) and one or more non-healing lower extremity arterial insufficiency ulcers who are suitable candidates for revascularization procedures (endovascular or surgical) will be randomized 1:1 to:
- Wound care with the use of OxyGenesys(TM) Dissolved Oxygen Dressing, or
- Standard Wound Care procedures
An initial study phase will enroll up to 20 subjects (10 in each arm). Pending results of the initial study phase, the study may continue to enroll until up to 50 subjects (25 in each arm) have been enrolled.
All subjects will be followed clinically and receive wound evaluation at 1, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxyGenesys(TM) Dissolved Oxygen Dressing | Experimental | Device: Oxygenesys(TM) Dissolved Oxygen DressingOxyGenesys(TM) Dissolved Oxygen Dressing |
| Standard Wound Care | No intervention | –Standard wound care using gauze dressings per institutional standard of care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female >=21 years of age
- A clinical diagnosis of critical limb ischemia (CLI) with Rutherford classification stage 5
- One or more chronic ulcers with a presumed etiology of arterial insufficiency and duration >2 weeks. The target ulcer is defined as the highest-grade ulcer (Wagner's classification) at initial evaluation. For wounds with identical grading, the largest wound is the index wound
- The patient or legally authorized representative is willing to provide informed consent and comply with specified follow-up evaluations
- Undergoing intervention for infrainguinal or infrapopliteal artery disease (below the femoral artery bifurcation and above the ankle joint)
Key exclusion criteria (15 listed)
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to index procedure.
- Rutherford classification stage 0,1,2,3,4, or 6
- Target wound duration <2 weeks
- Presence of frank gangrene (Wagner classification grade 4 or 5), major tissue loss (severe/extensive necrosis), or unsalvageable limb (extensive ischemic ulceration beyond the transmetatarsal level anticipated to require major amputation after the index procedure)
- Previous or planned surgical or interventional procedure within 6 months before or 30 days after the index procedure, or any previous or planned target limb amputation.
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 |
|---|---|---|
| Oxygenesys(TM) Dissolved Oxygen DressingOxyGenesys(TM) Dissolved Oxygen Dressing | Device | OxyGenesys(TM) Dissolved Oxygen Dressing |
Primary outcome
Rate of Wound Healing
Time frame: 3 months
Percentage reduction in target wound area (length x width).
1 secondary outcome
Incidence of Complete Wound Closure
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- 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.
Carlos Mena-Hurtado, MD principal investigator
Yale University
David T Curd, MS study director
Kimberly-Clark Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygenesys(TM) Dissolved Oxygen Dressing in people with Critical Limb Ischemia, run by Halyard Health at 1 site 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2015). 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?
Rate of Wound Healing (time frame: 3 months). 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 12 Oct 2015.