Trials / Terminated
TerminatedNCT03640988
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- SANUWAVE, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | dermaPACE | Shockwave application |
Timeline
- Start date
- 2019-04-25
- Primary completion
- 2021-01-03
- Completion
- 2021-01-03
- First posted
- 2018-08-21
- Last updated
- 2021-11-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03640988. Inclusion in this directory is not an endorsement.