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

NCT03640988 | Terminated FDA Device

• 1 other identifier: SAN18-DERM02
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Wound healing, effect on wound area, by visit

  10 weeks

• Wound healing, effect on wound closure, by visit

  10 weeks

Study Arms (1)

dermaPACE

EXPERIMENTAL

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

Interventions

dermaPACE DEVICE

Shockwave application

dermaPACE

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SANUWAVE, Inc.: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Mark Granick, MD FACS

  University Hospital/Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 21, 2018
• Study Start: April 25, 2019
• Primary Completion: January 3, 2021
• Study Completion: January 3, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)