Back to resultsThe Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
Primary Purpose
Diabetic Foot Ulcer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dermaPACE
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot Ulcer
Eligibility Criteria
Inclusion Criteria:
- Is male or female ≥22 years of age at Visit 1;
- Wagnergrade 1 or 2 DFU;
- 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
- 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.
- Has Type I or Type II Diabetes Mellitus;
- HbA1c < 12% at Visit 1;
- Patient is willing to comply with all study requirements and treatment visits.
- Patient is willing to comply with off-loading directions.
- 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:
- Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
- Known or suspected systemic infection;
- Enrolled in another investigational study;
- 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;
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
- Unable to tolerate offloading footwear or total contact casting (TCC);
- Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
- Has active Charcot foot at Visit 1 or 2;
- Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dermaPACE
Arm Description
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.
Outcomes
Primary Outcome Measures
Skin perfusion, effect on oxygenation level, by visit
Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.
Secondary Outcome Measures
Wound healing, effect on wound area, by visit
Measurement of changes in wound area at each visit
Wound healing, effect on wound closure, by visit
Measurement of the rate of wound closure at each visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640988
Brief Title
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
January 3, 2021 (Actual)
Study Completion Date
January 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SANUWAVE, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dermaPACE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
dermaPACE
Intervention Description
Shockwave application
Primary Outcome Measure Information:
Title
Skin perfusion, effect on oxygenation level, by visit
Description
Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Wound healing, effect on wound area, by visit
Description
Measurement of changes in wound area at each visit
Time Frame
10 weeks
Title
Wound healing, effect on wound closure, by visit
Description
Measurement of the rate of wound closure at each visit
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is male or female ≥22 years of age at Visit 1;
Wagnergrade 1 or 2 DFU;
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
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.
Has Type I or Type II Diabetes Mellitus;
HbA1c < 12% at Visit 1;
Patient is willing to comply with all study requirements and treatment visits.
Patient is willing to comply with off-loading directions.
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:
Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
Known or suspected systemic infection;
Enrolled in another investigational study;
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;
Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
Unable to tolerate offloading footwear or total contact casting (TCC);
Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
Has active Charcot foot at Visit 1 or 2;
Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Granick, MD FACS
Organizational Affiliation
University Hospital/Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
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