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

Not Applicable

Terminated

• Conditions: Diabetic Foot Ulcer
• Interventions: Device: dermaPACE

• Registration Number: NCT03640988
• Lead Sponsor: SANUWAVE, Inc.

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 Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2019-04-25
• Primary Completion: 2021-01-03
• Study Completion: 2021-01-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Is male or female ≥22 years of age at Visit 1;
2. Wagnergrade 1 or 2 DFU;
3. 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
4. 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.
5. Has Type I or Type II Diabetes Mellitus;
6. HbA1c < 12% at Visit 1;
7. Patient is willing to comply with all study requirements and treatment visits.
8. Patient is willing to comply with off-loading directions.
9. 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:

1. Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
2. Known or suspected systemic infection;
3. Enrolled in another investigational study;
4. 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;
5. Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
6. Unable to tolerate offloading footwear or total contact casting (TCC);
7. Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
8. Has active Charcot foot at Visit 1 or 2;
9. Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dermaPACE	dermaPACE	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.

Primary Outcome Measures

Name	Time	Method
Skin perfusion, effect on oxygenation level, by visit	10 weeks	Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.

Secondary Outcome Measures

Name	Time	Method
Wound healing, effect on wound area, by visit	10 weeks	Measurement of changes in wound area at each visit
Wound healing, effect on wound closure, by visit	10 weeks	Measurement of the rate of wound closure at each visit

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Newark, New Jersey, United States