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Diabetic Foot UlcersPhase 3NCT01824407

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

A Phase 3 study testing Electrohydraulic-generated shock wave in people with Diabetic Foot Ulcers, run by SANUWAVE, Inc. at 19 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Diabetic Foot Ulcers
What is being tested?
Electrohydraulic-generated shock wave
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
19 sitesin 2 countries
Study dates
Mar 2013to Apr 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is >=22 years of age at Visit 1;
  • 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;
  • 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
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  • Is postmenopausal for at least one year;
  • 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.
  • Has Type I or Type II Diabetes Mellitus with a HbA1c <= 11% at Visit 1;
  • Is capable of wound care at home;
  • Has a target ulcer >= 1.0 cm2 and <= 16 cm2 at Visits 1 and 2;
  • 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
  • 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;
  • Subject agrees, or if applicable, the subject's legal representative agrees that the subject can participate in the study

Who cannot join

  • Is currently pregnant or plans to become pregnant during the study;
  • Is nursing or actively lactating;
  • Is morbidly obese (Body Mass Index >= 40) at Visit 1;
  • Has clinically significant renal disease defined as having an estimated creatinine clearance of <=40mL/min at Visit 1;
  • Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2;
  • Has evidence of a prior ulcer in the same area as the target ulcer;
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  • Has a target ulcer that has decreased in volume by 50% or more at Visit 2 as compared to the volume at Visit 1;
  • 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;
  • Has a target ulcer that tunnels into wound tracks which cannot be fully visualized from the wound surface at Visit 1 or 2;
  • Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
  • Has a target ulcer that has visually purulent exudates or that has malodorous exudates on examination at Visit 1 or 2;
  • Has PVD, per Doppler Ultrasound, requiring vascular surgery intervention at Visit 1 or 2;
  • 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;
  • Has had a lower extremity revascularization procedure within eight weeks of Visit 1;
  • Has active Charcot foot at Visit 1 or 2;
  • Has had a surgical procedure to correct biomechanical abnormities within eight weeks of Visit 1;
  • Has had a deep vein thrombosis within six months of Visit 1;
  • Has clinical evidence of lymphedema at Visit 1;
  • Has had chemotherapy within 60 days of Visit 1;
  • Has a life expectancy <=2 years;
  • Has previously participated in a dermaPACE diabetic foot ulcer study;
  • Has had treatment of the target ulcer with growth factors, prostaglandin therapy, negative pressure or vasodilator therapy within two weeks of Visit 1;
  • Is receiving >=10 mg/day of steroid therapy;
  • Has sickle cell anemia;
  • Has a known immunodeficiency disorder to include, but not be limited to: AIDS, HIV, etc.
  • Has received radiation treatment within 120 days of Visit 1;
  • Has received treatment with immunosuppressants within sixty days of Visit 1;
  • Has received treatment with biologically active cellular products on the target ulcer, e.g. Apligraf®, Dermagraft®, etc. within sixty days of Visit 1;
  • Has received treatment with acellular (collagen-based) products on the target ulcer, e.g. Alloderm®, Integra®, etc. within 30 days of Visit 1;
  • Has a current history of substance abuse (current is defined as within 120 days of Visit 1);
  • Has a history of major systemic infections requiring hospitalization within three months of Visit 1 ;
  • 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;
  • Has a physical or mental disability or geographical concerns that would inhibit compliance with required study visits;
  • Is planning to undergo an exclusionary treatment or procedure during the study; or
  • Has participated in another investigation within 30 days of Visit 1

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States18 sites, 18 recruiting

  • Moore Foot and Ankle Specialists

    Asheville, North Carolina, 28806

    Lily Moore, DPM, 828-350-1880, Mfas828@aol.com

    J. Christopher Moore, DPM

    Recruiting

  • Northwestern University, Div of Plastic and Reconstructive Surgery

    Chicago, Illinois, 60611

    Catherine Piserchia, 312-695-6022, kpiserch@nmh.org

    Robert Galiano, MD

    Recruiting

  • Podiatric Medical Partners of Texas

    Dallas, Texas, 75224

    Rena Killebrew, 214-330-9299, renakillebrew@gmail.com

    Richard C Galperin, DPM

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Deanna S Adams, RN, 214-645-8907, deanna.adams@utsouthwestern.edu

    Lawrence Lavery, DPM

    Recruiting

  • Paul and Margaret Brand Research Center at Barry University

    Hialeah, Florida, 33013

    Maria Swartz, 305-836-7550, mswartz@mail.barry.edu

    Robert F Snyder, DPM

    Recruiting

  • The Research Center

    Hialeah, Florida, 33016

    Elisa Betancourt, 786-391-1928, research@doctor.com

    Gilberto J Acosta, DPM

    Recruiting

  • River City Clinical Research

    Jacksonville, Florida, 32207

    William Namen II, DPM, 904-861-3050, wnamen@encoredocs.com

    William Namen II, DPM

    Recruiting

  • Wound Center - ACMH

    Kittaning, Pennsylvania, 16201

    Heather Connell, 724-543-8993, connellh@acmh.org

    Matthew Sabo, DPM

    Recruiting

  • Long Beach VA Healthcare System

    Long Beach, California, 90822

    Nancy Anderson-Berman, 562-826-8000 ext. 2889, nancy.berman@va.gov

    Ian Gordon, MD, PhD

    Recruiting

  • Foot and Ankle Clinic

    Los Angeles, California, 90010

    Suni Allen, 213-365-0793, sunigmka@aol.com

    Felix Sigal, DPM

    Recruiting

  • St. Paul Medical Research

    Miami, Florida, 33126

    Jacqueline Gorra, 305-507-8237, sitedirectorjg@gmail.com

    John G Padron, MD

    Recruiting

  • Advanced Pharma CR

    Miami, Florida, 33137

    Yvette Lopez, 305-220-2727, Ilopez@advancedpharma.com

    Gilbert Weiner, MD

    Recruiting

  • Alameda County Medical Center - Highlands Campus

    Oakland, California, 94602

    Kathleen Edmunds, 510-869-6511 ext. 5629, kedmunds@samuelmerritt.edu

    Timothy Dutra, DPM

    Recruiting

  • Associated Foot and Ankle Specialists

    Phoenix, Arizona, 85015

    Norma Ramos, 602-339-8262, norma.ramos@questoffice.net

    Arthur Tallis, DPM

    Recruiting

  • Foot and Ankle Associates of SW Virginia

    Roanoke, Virginia, 24016

    Morgan Stepanek, 540-797-2726, mstepanek@periedu.com

    Charles M. Zelen, DPM

    Recruiting

  • Lucius J. Hill DPM

    San Bernardino, California, 92404

    Brittany Griffith, 909-886-7700, bgriffith@trialogic.com

    Lucius J Hill, DPM

    Recruiting

  • Foot Healthcare Associates

    Southfield, Michigan, 48076

    Sonja Gerald, 248-798-7168, sgerald@michiganpodiatry.com

    Neal Mozen, DPM

    Recruiting

  • Southern Arizona VA Healthcare System

    Tucson, Arizona, 85723

    Phyllis Houston, 520-792-1450 ext. 4548, Phyllis.Houston@va.gov

    Jodi L Walters, DPM

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • The Mayer Institute

    Hamilton, Ontario, L8R 2R3

    Ivana Roth-Albin, 905-523-1444 ext. 232, roth.ivana@gmail.com

    Perry Mayer, MD

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
Electrohydraulic-generated shock wave, Sham device plus standard of care
Keywords
foot, ulcers, diabetes, wound, healing
Medical subject headings
Diabetic Foot, Ulcer, Diabetes Mellitus, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrohydraulic-generated shock waveDevice

    Also called dermaPACE

  • Sham device plus standard of careDevice

Study groups in NCT01824407
Study groupRoleWhat they receive
Active device plus standard of careActive comparatorActive device plus standard of care
Receives: Device: Electrohydraulic-generated shock wave
Sham device plus standard of careSham comparatordermaPACE device that uses a dummy applicator that does not emit shock waves
Receives: Device: Sham device plus standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (4)

  1. Volumetric reduction

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

    Measured: 12 weeks

  2. Area reduction

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

    Measured: 12 weeks

  3. Rate of recurrence

    Measured: 24 weeks

  4. Rate of amputation and other adverse events

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01824407
Sponsor's protocol ID
SAN12-DERM02
Status last verified
Mar 2014
First submitted
1 Apr 2013
Last updated
6 Mar 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Electrohydraulic-generated shock wave in people with Diabetic Foot Ulcers, run by SANUWAVE, Inc. at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete closure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01824407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.

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