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
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- SANUWAVE, Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Skin perfusion, effect on oxygenation level, by visit
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
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 Outcomes
- Wound healing, effect on wound area, by visit(10 weeks)
- Wound healing, effect on wound closure, by visit(10 weeks)