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The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640988
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
SANUWAVE, Inc.

Brief Summary:
This is an observational, single-arm study. This clinical study will be conducted at up to 4 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: dermaPACE Not Applicable

Detailed Description:
The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pulsed acoustic wave application on acute and chronic defects of the skin and subcutaneous soft tissues
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Post-market Pilot Study to Evaluate the Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and Healing of Diabetic Foot Ulcers
Estimated Study Start Date : September 3, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dermaPACE
Non-sterile, single, Benchtop System that is comprised of a dermaPACE Control Console, PACE Applicator and foot pedal. The PACE applicator uses shockwave technology on acute and chronic defects.
Device: dermaPACE
Shockwave application




Primary Outcome Measures :
  1. Skin perfusion, effect on oxygenation level, by visit [ Time Frame: 10 weeks ]
    Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.


Secondary Outcome Measures :
  1. Wound healing, effect on wound area, by visit [ Time Frame: 10 weeks ]
    Measurement of changes in wound area at each visit

  2. Wound healing, effect on wound closure, by visit [ Time Frame: 10 weeks ]
    Measurement of the rate of wound closure at each visit



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Is male or female ≥22 years of age at Visit 1;
  2. Wagnergrade 1 or 2 DFU;
  3. 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 at Visit 1
  4. Has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit.
  5. Has Type I or Type II Diabetes Mellitus;
  6. HbA1c < 12% at Visit 1;
  7. Patient is willing to comply with all study requirements and treatment visits.
  8. Patient is willing to comply with off-loading directions.
  9. Patient is willing to comply with offloading instructions

Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study.

A subject who:

  1. Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
  2. Known or suspected systemic infection;
  3. Enrolled in another investigational study;
  4. Has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment;
  5. Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
  6. Unable to tolerate offloading footwear or total contact casting (TCC);
  7. Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
  8. Has active Charcot foot at Visit 1 or 2;
  9. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640988


Contacts
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Contact: Pete Stegagno 678-578-0111 pete.stegagno@sanuwave.com

Sponsors and Collaborators
SANUWAVE, Inc.
Investigators
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Principal Investigator: Oscar Alvarez, PhD CCT FAPWCA University Hospital
Principal Investigator: Askone Nouvong, DPM FACFAS University of California, Los Angeles
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Responsible Party: SANUWAVE, Inc.
ClinicalTrials.gov Identifier: NCT03640988    
Other Study ID Numbers: SAN18-DERM02
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases