The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
Stopped early · Not applicable
Conditions studied: Diabetic Foot Ulcer
In brief
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.
Key facts
- Study ID
- NCT03640988
- Run by
- SANUWAVE, Inc.
- People needed
- 2
- Starts
- 2019-04-25
- Expected to finish
- 2021-01-03
- Last updated by the study team
- 2021-11-08
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospital — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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