Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia

NCT02046226 | Terminated Results

• 1 other identifier: 100-13-0001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Limb Ischemia

Keywords

Critical Limb Ischemia; Non Healing Wounds; Diabetic Wounds; Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Rate of Wound Healing

  Percentage reduction in target wound area (length x width).

  3 months

Secondary Outcomes (1)

• Incidence of Complete Wound Closure

  3 months

Study Arms (2)

OxyGenesys(TM) Dissolved Oxygen Dressing

EXPERIMENTAL

OxyGenesys(TM) Dissolved Oxygen Dressing

Device: Oxygenesys(TM) Dissolved Oxygen Dressing

Standard Wound Care

NO INTERVENTION

Standard wound care using gauze dressings per institutional standard of care.

Interventions

Oxygenesys(TM) Dissolved Oxygen Dressing DEVICE

OxyGenesys(TM) Dissolved Oxygen Dressing

OxyGenesys(TM) Dissolved Oxygen Dressing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Halyard Health: lead
• Yale University: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Foot Ulcer

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Results Point of Contact

• Title: David T Curd
• Organization: Halyard Health, Inc.

david.curd@hyh.com

470-448-5178

Study Officials

• Carlos Mena-Hurtado, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• David T Curd, MS

  Kimberly-Clark Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: October 12, 2015
• Results First Posted: October 12, 2015

Record last verified: 2014-11

Locations

US (1)