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

NCT ID: NCT03640988

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-25
• Study Completion Date: 2021-01-03

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

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dermaPACE

Intervention Type: DEVICE

Shockwave application

Interventions

dermaPACE

Shockwave application

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SANUWAVE, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Granick, MD FACS

Role: PRINCIPAL_INVESTIGATOR

University Hospital/Rutgers University

Locations

University Hospital

Newark, New Jersey, United States

Countries

United States

Other Identifiers

SAN18-DERM02

Identifier Type: -

Identifier Source: org_study_id