A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by SANUWAVE, Inc.
Sponsor:
Information provided by (Responsible Party):
SANUWAVE, Inc.
ClinicalTrials.gov Identifier:
NCT01824407
First received: April 1, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational.

The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.


Condition Intervention Phase
Diabetic Foot Ulcers
Device: Electrohydraulic-generated shock wave
Device: Sham device plus standard of care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Multi-center, Randomized, Sham-Controlled, Parallel Group Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With Standard of Care Versus Standard of Care Alone in the Treatment of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by SANUWAVE, Inc.:

Primary Outcome Measures:
  • Complete closure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Complete closure will be assessed by visual inspection by the principal or sub-investigator according to the following complete closure definition: 100% skin re-epithelializion without drainage or dressing requirements confirmed at two consecutive study visits. A re-epithelialized target ulcer is defined as the tissue surface having at least a thin layer of epithelium covering the prior, previously denuded, target ulcer area.


Secondary Outcome Measures:
  • Volumetric reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Digital planimetry will be used to assess volumetric reduction between follow-up visits.

  • Area reduction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Digital planimetry will be used to assess area reduction between follow-up visits.

  • Rate of recurrence [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of amputation and other adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active device plus standard of care
Active device plus standard of care
Device: Electrohydraulic-generated shock wave
Other Name: dermaPACE
Sham Comparator: Sham device plus standard of care
dermaPACE device that uses a dummy applicator that does not emit shock waves
Device: Sham device plus standard of care

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is >=22 years of age at Visit 1;
  2. If female of child-bearing potential, both of the following must be met at Visit 1:

    • Practices one of the following methods of contraception and continues through the duration of the study: hormonal contraceptives, IUD, spermicide and barrier or implantable device, and
    • Has a negative urine qualitative beta-HCG pregnancy test;
  3. If female and post-menopausal one of the following must be met at Visit 1:

    • Has had a complete hysterectomy, bilateral salpingo-oophorectomy or tubal ligation or otherwise be incapable of pregnancy, or
    • Is postmenopausal for at least one year;
  4. Has at least one DFU that is located in the ankle area or below that has persisted a minimum of 30 days prior to Visit 1.
  5. Has Type I or Type II Diabetes Mellitus with a HbA1c <= 11% at Visit 1;
  6. Is capable of wound care at home;
  7. Has a target ulcer >= 1.0 cm2 and <= 16 cm2 at Visits 1 and 2;
  8. Has a target ulcer that is Grade 1 or 2, Stage A according to the University of Texas Diabetic Wound Classification system, at Visits 1 and 2
  9. In the leg with the target ulcer has an ABI >= 0.70 and <= 1.20 OR if the ABI is >1.20 has a toe pressure >50 mmHg OR tcpO2 > 40 mmHg at Visit 1;
  10. Subject agrees, or if applicable, the subject's legal representative agrees that the subject can participate in the study

Exclusion Criteria:

  1. Is currently pregnant or plans to become pregnant during the study;
  2. Is nursing or actively lactating;
  3. Is morbidly obese (Body Mass Index >= 40) at Visit 1;
  4. Has clinically significant renal disease defined as having an estimated creatinine clearance of <=40mL/min at Visit 1;
  5. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2;
  6. Has evidence of a prior ulcer in the same area as the target ulcer;
  7. Has a target ulcer that has decreased in volume by 50% or more at Visit 2 as compared to the volume at Visit 1;
  8. Has multiple foot ulcers that are connected by fistulas or has an ulcer(s) that are within 5 cm of the target ulcer at Visit 1 or 2;
  9. Has a target ulcer that tunnels into wound tracks which cannot be fully visualized from the wound surface at Visit 1 or 2;
  10. Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
  11. Has a target ulcer that has visually purulent exudates or that has malodorous exudates on examination at Visit 1 or 2;
  12. Has PVD, per Doppler Ultrasound, requiring vascular surgery intervention at Visit 1 or 2;
  13. Requires use of off-loading Diabetic Walker device for the foot intended for study application for a reason other than for a target ulcer on the plantar surface of the foot at Visit 1 or 2;
  14. Has had a lower extremity revascularization procedure within eight weeks of Visit 1;
  15. Has active Charcot foot at Visit 1 or 2;
  16. Has had a surgical procedure to correct biomechanical abnormities within eight weeks of Visit 1;
  17. Has had a deep vein thrombosis within six months of Visit 1;
  18. Has clinical evidence of lymphedema at Visit 1;
  19. Has had chemotherapy within 60 days of Visit 1;
  20. Has a life expectancy <=2 years;
  21. Has previously participated in a dermaPACE diabetic foot ulcer study;
  22. Has had treatment of the target ulcer with growth factors, prostaglandin therapy, negative pressure or vasodilator therapy within two weeks of Visit 1;
  23. Is receiving >=10 mg/day of steroid therapy;
  24. Has sickle cell anemia;
  25. Has a known immunodeficiency disorder to include, but not be limited to: AIDS, HIV, etc.
  26. Has received radiation treatment within 120 days of Visit 1;
  27. Has received treatment with immunosuppressants within sixty days of Visit 1;
  28. Has received treatment with biologically active cellular products on the target ulcer, e.g. Apligraf®, Dermagraft®, etc. within sixty days of Visit 1;
  29. Has received treatment with acellular (collagen-based) products on the target ulcer, e.g. Alloderm®, Integra®, etc. within 30 days of Visit 1;
  30. Has a current history of substance abuse (current is defined as within 120 days of Visit 1);
  31. Has a history of major systemic infections requiring hospitalization within three months of Visit 1 ;
  32. Has a current malignancy or a history of malignancy within five years, of Visit 1 except for basal cell carcinoma that has been treated with local excision and is no longer present;
  33. Has a physical or mental disability or geographical concerns that would inhibit compliance with required study visits;
  34. Is planning to undergo an exclusionary treatment or procedure during the study; or
  35. Has participated in another investigation within 30 days of Visit 1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01824407

Locations
United States, Arizona
Associated Foot and Ankle Specialists Recruiting
Phoenix, Arizona, United States, 85015
Contact: Norma Ramos    602-339-8262    norma.ramos@questoffice.net   
Principal Investigator: Arthur Tallis, DPM         
Southern Arizona VA Healthcare System Recruiting
Tucson, Arizona, United States, 85723
Contact: Phyllis Houston    520-792-1450 ext 4548    Phyllis.Houston@va.gov   
Principal Investigator: Jodi L Walters, DPM         
United States, California
Long Beach VA Healthcare System Recruiting
Long Beach, California, United States, 90822
Contact: Nancy Anderson-Berman    562-826-8000 ext 2889    nancy.berman@va.gov   
Principal Investigator: Ian Gordon, MD, PhD         
Foot and Ankle Clinic Recruiting
Los Angeles, California, United States, 90010
Contact: Suni Allen    213-365-0793    sunigmka@aol.com   
Principal Investigator: Felix Sigal, DPM         
Alameda County Medical Center - Highlands Campus Recruiting
Oakland, California, United States, 94602
Contact: Kathleen Edmunds    510-869-6511 ext 5629    kedmunds@samuelmerritt.edu   
Principal Investigator: Timothy Dutra, DPM         
Lucius J. Hill DPM Recruiting
San Bernardino, California, United States, 92404
Contact: Brittany Griffith    909-886-7700    bgriffith@trialogic.com   
Principal Investigator: Lucius J Hill, DPM         
United States, Florida
The Research Center Recruiting
Hialeah, Florida, United States, 33016
Contact: Elisa Betancourt    786-391-1928    research@doctor.com   
Principal Investigator: Gilberto J Acosta, DPM         
Paul and Margaret Brand Research Center at Barry University Recruiting
Hialeah, Florida, United States, 33013
Contact: Maria Swartz    305-836-7550    mswartz@mail.barry.edu   
Principal Investigator: Robert F Snyder, DPM         
River City Clinical Research Recruiting
Jacksonville, Florida, United States, 32207
Contact: William Namen II, DPM    904-861-3050    wnamen@encoredocs.com   
Principal Investigator: William Namen II, DPM         
Advanced Pharma CR Recruiting
Miami, Florida, United States, 33137
Contact: Yvette Lopez    305-220-2727    Ilopez@advancedpharma.com   
Principal Investigator: Gilbert Weiner, MD         
St. Paul Medical Research Recruiting
Miami, Florida, United States, 33126
Contact: Jacqueline Gorra    305-507-8237    sitedirectorjg@gmail.com   
Principal Investigator: John G Padron, MD         
United States, Illinois
Northwestern University, Div of Plastic and Reconstructive Surgery Recruiting
Chicago, Illinois, United States, 60611
Contact: Catherine Piserchia    312-695-6022    kpiserch@nmh.org   
Principal Investigator: Robert Galiano, MD         
United States, Michigan
Foot Healthcare Associates Recruiting
Southfield, Michigan, United States, 48076
Contact: Sonja Gerald    248-798-7168    sgerald@michiganpodiatry.com   
Principal Investigator: Neal Mozen, DPM         
United States, North Carolina
Moore Foot and Ankle Specialists Recruiting
Asheville, North Carolina, United States, 28806
Contact: Lily Moore, DPM    828-350-1880    Mfas828@aol.com   
Principal Investigator: J. Christopher Moore, DPM         
United States, Pennsylvania
Wound Center - ACMH Recruiting
Kittaning, Pennsylvania, United States, 16201
Contact: Heather Connell    724-543-8993    connellh@acmh.org   
Principal Investigator: Matthew Sabo, DPM         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Deanna S Adams, RN    214-645-8907    deanna.adams@utsouthwestern.edu   
Principal Investigator: Lawrence Lavery, DPM         
Podiatric Medical Partners of Texas Recruiting
Dallas, Texas, United States, 75224
Contact: Rena Killebrew    214-330-9299    renakillebrew@gmail.com   
Principal Investigator: Richard C Galperin, DPM         
United States, Virginia
Foot and Ankle Associates of SW Virginia Recruiting
Roanoke, Virginia, United States, 24016
Contact: Morgan Stepanek    540-797-2726    mstepanek@periedu.com   
Principal Investigator: Charles M. Zelen, DPM         
Canada, Ontario
The Mayer Institute Recruiting
Hamilton, Ontario, Canada, L8R 2R3
Contact: Ivana Roth-Albin    905-523-1444 ext 232    roth.ivana@gmail.com   
Principal Investigator: Perry Mayer, MD         
Sponsors and Collaborators
SANUWAVE, Inc.
  More Information

No publications provided

Responsible Party: SANUWAVE, Inc.
ClinicalTrials.gov Identifier: NCT01824407     History of Changes
Other Study ID Numbers: SAN12-DERM02
Study First Received: April 1, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by SANUWAVE, Inc.:
foot
ulcers
diabetes
wound
healing

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

ClinicalTrials.gov processed this record on October 20, 2014