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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03640988
• Other study ID #: SAN18-DERM02
• Status: Terminated
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: January 3, 2021

Study information

• Verified date: October 2021
• Source: SANUWAVE, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 3, 2021
• Est. primary completion date: January 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer

Intervention

Device:
• dermaPACE
Shockwave application

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
SANUWAVE, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound healing, effect on wound area, by visit	Measurement of changes in wound area at each visit	10 weeks
Secondary	Wound healing, effect on wound closure, by visit	Measurement of the rate of wound closure at each visit	10 weeks