Electrical Stimulation as an Adjunctive Therapy to Increase Vascular Perfusion in People With PAD or PVD

NCT04313985 | Terminated Results FDA Device

• 1 other identifier: 45628
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to apply Avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.

Conditions

PAD - Peripheral Arterial Disease; PVD- Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Wound Tissue Perfusion

  To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)

  Day 7 of the respective treatment period

Secondary Outcomes (3)

• Percent Change in Wound Area as a Measure of Healing Rate

  Day 7 of the respective treatment period

• Bacterial Biopsies

  From time of randomization up until wound healing or 3 weeks, whichever came first

• Pain Score

  Day 7 of the respective treatment period

Study Arms (2)

Electrical Stimulation First, then Sham Stimulation

ACTIVE COMPARATOR

Treat the patient's wound area: Place self-adhesive, conductive electrode pads on either side of the wound on the skin where the pads are not placed in the open wound itself, but rather in the surrounding area with one pad on each side of the wound. Connect the pads to the lead wire to the Avazzia device. Turn on the Avazzia device and change modes to the RSI mode. Increase power to maximum comfortable power level for the patient. If the patient cannot feel the output, then increase power to 250. Instruct the patient to reduce the power level if it begins to feel too strong. (sometimes as the microstimulation is applied, the tissue will become more sensitive to the stimulation. In this case the power should be reduced for patient comfort.) Allow to run unattended for 15 minutes. Take a picture of the pad placement and display on the device to document location, power setting, and treatment mode while the treatment is running for the 15 minutes.

Device: Tennant Biomodulator-Pro™ Device

Sham Electrical Stimulation First, then Electrical Stimulation

SHAM COMPARATOR

Treat the patient's wound area: Place self-adhesive, conductive electrode pads on either side of the wound on the skin where the pads are not placed in the open wound itself, but rather in the surrounding area with one pad on each side of the wound. Connect the pads to the lead wire to the Avazzia device. Turn on the Avazzia device and change modes to the RSI mode. Increase power to maximum comfortable power level for the patient. If the patient cannot feel the output, then increase power to 250. Instruct the patient to reduce the power level if it begins to feel too strong. (sometimes as the microstimulation is applied, the tissue will become more sensitive to the stimulation. In this case the power should be reduced for patient comfort.) Allow to run unattended for 15 minutes. Take a picture of the pad placement and display on the device to document location, power setting, and treatment mode while the treatment is running for the 15 minutes.

Device: Tennant Biomodulator-Pro™ Device

Interventions

Tennant Biomodulator-Pro™ Device DEVICE

Tennant Biomodulator-Pro™ conductive electrode pads will be placed on both sides of the wound. The device will either deliver electrical stimulation or no stimulation depending on treatment period.

Electrical Stimulation First, then Sham Stimulation; Sham Electrical Stimulation First, then Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has a chronic non-healing wound that has not healed in 30 days in their feet, legs, lower back or buttocks, but not in their hands because the hands will be used to verify equipment operation.
• Age ≥18 and ≤70 years
• Wound area is ≥0.5 cm2 and ≤22 cm2
• Willing and able to comply with weekly visits to clinic (e.g., reliable transportation)

You may not qualify if:

• Presence of an electrical implant such as a cardiac pacemaker or neural stimulator
• Patient is currently pregnant, possibly pregnant or breast-feeding User of any microcurrent device in the past six (6) months prior to enrollment in the study
• Patient is experiencing a medical emergency
• Patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity
• Patient is diagnosed with Charcot-Marie-Tooth or similar genetically inheritable neuropathic disease(s)
• Patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency
• Patient is diagnosed with malignancies (cancers) undergoing treatment

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Advanced Wound Care Center

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

This study fell far short of it's planned enrollment size and failed to achieve statistical power.

Results Point of Contact

• Title: Geoffrey Gurtner
• Organization: Stanford University

gurtner@surgery.arizona.edu

(520) 626-2222

Study Officials

• Geoffrey C Gurtner, MD

  Stanford University School of Medicine- Plastic & Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both the participant and the care provider will be masked as to what treatment the participant is receiving during each study visit. Only the study coordinator will know which treatment is being conducted.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: March 18, 2020
• Study Start: August 1, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)