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

Diabetic Foot Ulcers Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01824407
• Other study ID #: SAN12-DERM02
• Status: Recruiting
• Phase: Phase 3
• First received: April 1, 2013
• Last updated: March 4, 2014
• Start date: March 2013

Study information

• Verified date: March 2014
• Source: SANUWAVE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• Electrohydraulic-generated shock wave

• Sham device plus standard of care

Locations

Country	Name	City	State
Canada	The Mayer Institute	Hamilton	Ontario
United States	Moore Foot and Ankle Specialists	Asheville	North Carolina
United States	Northwestern University, Div of Plastic and Reconstructive Surgery	Chicago	Illinois
United States	Podiatric Medical Partners of Texas	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Paul and Margaret Brand Research Center at Barry University	Hialeah	Florida
United States	The Research Center	Hialeah	Florida
United States	River City Clinical Research	Jacksonville	Florida
United States	Wound Center - ACMH	Kittaning	Pennsylvania
United States	Long Beach VA Healthcare System	Long Beach	California
United States	Foot and Ankle Clinic	Los Angeles	California
United States	Advanced Pharma CR	Miami	Florida
United States	St. Paul Medical Research	Miami	Florida
United States	Alameda County Medical Center - Highlands Campus	Oakland	California
United States	Associated Foot and Ankle Specialists	Phoenix	Arizona
United States	Foot and Ankle Associates of SW Virginia	Roanoke	Virginia
United States	Lucius J. Hill DPM	San Bernardino	California
United States	Foot Healthcare Associates	Southfield	Michigan
United States	Southern Arizona VA Healthcare System	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SANUWAVE, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete closure	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.	12 weeks	No
Secondary	Volumetric reduction	Digital planimetry will be used to assess volumetric reduction between follow-up visits.	12 weeks	No
Secondary	Area reduction	Digital planimetry will be used to assess area reduction between follow-up visits.	12 weeks	No
Secondary	Rate of recurrence		24 weeks	No
Secondary	Rate of amputation and other adverse events		24 weeks	Yes