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

Study 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

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

Conditions
-----------------
Diabetic Foot Ulcer

Intervention / Treatment
-----------------
* Device: dermaPACE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dermaPACE<br>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<br>* Shockwave application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin perfusion, effect on oxygenation level, by visit | Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing, effect on wound area, by visit | Measurement of changes in wound area at each visit | 10 weeks | 
| Wound healing, effect on wound closure, by visit | Measurement of the rate of wound closure at each visit | 10 weeks |