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Trial record 48 of 113 for:    Recruiting, Not yet recruiting, Available Studies | "Diabetic Foot"

Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT03398538
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Professional Education and Research Institute

Brief Summary:
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Ulcer Foot Diabetic Foot Other: Offloading Other: Additional (outer) Dressing Application Other: Mirragen Wound Matrix Dressing Other: Fibracol Wound Dressing Not Applicable

Detailed Description:

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment.

There are two standard of care arms in the study:

Arm 1: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with bioactive resorbable glass fiber dressing, MIRRAGEN™Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).

Arm 2: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Resorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mirragen Wound Matrix Dressing
MIRRAGEN™ Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix dressing to be used per manufacturer instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing
Other: Offloading
Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
Other Name: Pressure relief

Other: Additional (outer) Dressing Application
Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
Other Name: Outer protective dressing

Other: Mirragen Wound Matrix Dressing
Application of Mirragen to wound site along with standard of care treatment

Active Comparator: Fibracol Wound Dressing
A commercially available wound dressing to be used per manufacturer's instructions for use on diabetic foot wounds in conjunction with offloading and Additional (outer) Dressing Application with moisture retention dressing moisture retention dressing
Other: Offloading
Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
Other Name: Pressure relief

Other: Additional (outer) Dressing Application
Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
Other Name: Outer protective dressing

Other: Fibracol Wound Dressing
Application of Fibracol Alginate along with standard of care treatment




Primary Outcome Measures :
  1. Percentage of index ulcers healed at 12 weeks [ Time Frame: 12 weeks ]
    examine percent of ulcers healed at week twelve


Secondary Outcome Measures :
  1. Percentage of index ulcers healed at 6 weeks [ Time Frame: 6 week ]
    examine percent of ulcers healed at week six

  2. Time to heal within 6 and 12 weeks [ Time Frame: 6 and 12 weeks ]
    examine time to healing at both six and twelve weeks

  3. Percent Area Reduction (PAR) at 6 and 12 weeks [ Time Frame: 6 and 12 weeks ]
    examine PAR at both six and twelve weeks

  4. Changes in peripheral neuropathy using Semmes Weinstein Monofilament "10"point discrimination test [ Time Frame: 12 weeks ]
    Each clinical trial participant will be examined by the principal investigator with a Semmes Weinstein monofilament wire at 10 points on the study foot, this standardized exam will be scored out of a total of 10 at each visit and recorded

  5. Changes in wound quality of life, the " Wound Quality of Life Questionnaire" will be given to the clinical trial participants and administered during each visit [ Time Frame: 12 weeks ]
    The Wound-QoL, or wound quality of life questionnaire, measures the disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which are always assessed in retrospect to the preceding seven days. This questionnaire will be given to clinical trial participants at each visit, with the scale scores recorded. Each question is scored. Answers to each item are coded with numbers (0='not at all' to 4='very much'). As noted above the score will be reported with a minimam score of "0" and a maximum score of 68

  6. Change in pain levels during trial, using the FACES pain scales which measure pain on a range of 0-10, zero being no pain and 10 being the most severe pain [ Time Frame: 12 weeks ]
    The FACES pain scale will be administered to the clinical trial participants at each visit. The trial participant will select their pain level with a series of faces that correspond to a number between 0 which implies no pain , up to 10 which implies the most severe pain. The scores will be recorded for each clinical trial participant on each visit

  7. Difference in cellulitis and/or infection at 12 weeks [ Time Frame: 12 weeks ]
    Examine difference in infection rate over twelve weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old.
  • Presence of a DFU, Wagner 1 (see Appendix B for definitions), extending at least through the dermis provided it is below the medial aspect of the malleolus.
  • The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer.
  • Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
  • Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
  • Adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 within 3 months of SV1, using the affected study extremity. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a Toe Brachial Index (TBI) of > 0.6 is acceptable.
  • The target ulcer has been offloaded for at least 14 days prior to randomization.
  • Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
  • Subject understands and is willing to participate in the clinical study and can comply with weekly visits.

Exclusion Criteria:

  • Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
  • Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
  • Subjects with a history of more than two weeks treatment with immune-suppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study.
  • Subjects taking a selective COX-2 inhibitor, such as Celecoxib, for any condition.
  • Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding SV1.
  • History of radiation at the ulcer site (regardless of time since last radiation treatment).
  • Index ulcer has been previously treated or will need to be treated with any prohibited therapies. (See Section 7.3 of this protocol for a list of prohibited medications and therapies).
  • Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment.
  • Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to randomization. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision).
  • Subject is pregnant or breast-feeding.
  • Presence of diabetes with poor metabolic control as documented with an HbA1c > 12.0 within 90 days of randomization.
  • Subjects with end stage renal disease as evidenced by a serum creatinine ≥ 3.0 mg/dL within 6 months of randomization.
  • Index ulcer has reduced in area by 20% or more after 14 days of SOC from SV1 to the TV1/randomization visit.

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 ClinicalTrials.gov identifier (NCT number): NCT03398538


Contacts
Contact: Charles M Zelen, DPM 540 797 2726 cmzelen@periedu.com
Contact: Morgan T Stepanek, MBA 540 797 2726 mstepanek@periedu.com

Locations
United States, Missouri
Alan M Jacobs and Associates Not yet recruiting
Saint Louis, Missouri, United States, 63117
Contact: Florence Jacobs       drjacobs0902@sbcglobal.net   
Principal Investigator: Alan Jacobs, DPM         
United States, Ohio
Lower Extremity Institute of Research and Therapy Not yet recruiting
Youngstown, Ohio, United States, 44512
Contact: maura maloney, JD       malyn778@aol.com   
Contact: Diana Carpenter         
Principal Investigator: Lawrence Didomenico, DPM         
United States, Virginia
Martinsville Research Institute Not yet recruiting
Martinsville, Virginia, United States, 23116
Contact: Kim Young       kyoung@periedu.com   
Principal Investigator: Nathan Young, DPM         
Professional Education and Research Institute Recruiting
Roanoke, Virginia, United States, 24016
Contact: Charles Zelen, DPM    540-797-2726    cmzelen@periedu.com   
Contact: Morgan Stepanek, MBA    540 797 2726    mstepanek@periedu.com   
Principal Investigator: Chalres m Zelen, DPM         
Shenandoah Lower Extremity Research Institute Not yet recruiting
Troutville, Virginia, United States, 24019
Contact: Valerie Henesy       drkeller@shenandoahpodiatry.com   
Principal Investigator: Jennifer Keller, DPM         
Sponsors and Collaborators
Professional Education and Research Institute
Investigators
Principal Investigator: David Armstrong, DPM, MD, PhD USC / Salsa
Principal Investigator: Charles M Zelen, DPM Professional Education and Research Institute

Responsible Party: Professional Education and Research Institute
ClinicalTrials.gov Identifier: NCT03398538     History of Changes
Other Study ID Numbers: ETS-MG-01
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Professional Education and Research Institute:
DFU
Ulcer

Additional relevant MeSH terms:
Diabetic Foot
Ulcer
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