Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

June 30, 2010

Study Completion Date

September 30, 2010

Conditions
Diabetic Foot Ulcers
Interventions
DEVICE

acoustical pulse energy (extracorporeal shockwave)

Acoustical pulse energy (extracorporeal shockwave) + Standard of care wound dressing.

OTHER

Sham

Non-energized (inactive - Sham) application + standard of care

Trial Locations (23)

10461

Center for Palliative Wound Care; Calvary Hospital, The Bronx

30329

Emory Orthopedic and Spine Center, Atlanta

37203

Nashville Family Footcare, Nashville

43221

Ohio State University, Columbus

44115

St. Vincent's Charity Hospital, Cleveland

48431

Mathias Spital, Rheine

53215

Aurora Health Care, Milwaukee

55905

Mayo Clinic, Rochester

60611

Northwestern Univ. Div. of Plastic Surgery, Chicago

75224

Richard Galperin, DPM, PA, Dallas

78212

Robert Wunderlich, DPM, PA, San Antonio

78501

Complete Family Foot Care, McAllen

85012

Phoenix VA Health Care System, Phoenix

85050

HOPE Research Insititute, Phoenix

85723

Southern Arizona VA Healthcare System (SAVAHCS), Tucson

90822

Veterans Administration Long Beach Healthcare, Long Beach

91342

Olive View - UCLA Medical Center, Sylmar

94115

Center for Clinical Research, Castro Valley

06515

North American Center for Limb Preservation, New Haven

06851

Fairfield County Foot Surgeons, Norwalk

02118

Boston Medical Center, Boston

02215

Beth Israel Deaconess Medical Center, Boston

SE59RS

Kings College Hospital, London

All Listed Sponsors
lead

SANUWAVE, Inc.

INDUSTRY

NCT00536744 - Effectiveness of dermaPACE™ Device and Standard Treatment Compared to Standard Treatment Alone for Diabetic Foot Ulcers | Biotech Hunter | Biotech Hunter