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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by SANUWAVE, Inc..
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 1, 2013
Last updated: March 4, 2014
Last verified: March 2014

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
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 ]
    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 ]
    Digital planimetry will be used to assess volumetric reduction between follow-up visits.

  • Area reduction [ Time Frame: 12 weeks ]
    Digital planimetry will be used to assess area reduction between follow-up visits.

  • Rate of recurrence [ Time Frame: 24 weeks ]
  • Rate of amputation and other adverse events [ Time Frame: 24 weeks ]

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


Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

United States, Arizona
Associated Foot and Ankle Specialists
Phoenix, Arizona, United States, 85015
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
United States, California
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
Foot and Ankle Clinic
Los Angeles, California, United States, 90010
Alameda County Medical Center - Highlands Campus
Oakland, California, United States, 94602
Lucius J. Hill DPM
San Bernardino, California, United States, 92404
United States, Florida
Paul and Margaret Brand Research Center at Barry University
Hialeah, Florida, United States, 33013
The Research Center
Hialeah, Florida, United States, 33016
River City Clinical Research
Jacksonville, Florida, United States, 32207
St. Paul Medical Research
Miami, Florida, United States, 33126
Advanced Pharma CR
Miami, Florida, United States, 33137
United States, Illinois
Northwestern University, Div of Plastic and Reconstructive Surgery
Chicago, Illinois, United States, 60611
United States, Michigan
Foot Healthcare Associates
Southfield, Michigan, United States, 48076
United States, North Carolina
Moore Foot and Ankle Specialists
Asheville, North Carolina, United States, 28806
United States, Pennsylvania
Wound Center - ACMH
Kittaning, Pennsylvania, United States, 16201
United States, Texas
Podiatric Medical Partners of Texas
Dallas, Texas, United States, 75224
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Virginia
Foot and Ankle Associates of SW Virginia
Roanoke, Virginia, United States, 24016
Canada, Ontario
The Mayer Institute
Hamilton, Ontario, Canada, L8R 2R3
Sponsors and Collaborators
  More Information

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

Keywords provided by SANUWAVE, Inc.:

Additional relevant MeSH terms:
Diabetic Foot
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

ClinicalTrials.gov processed this record on January 23, 2017