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

Not Applicable

Terminated

• Conditions: PVD- Peripheral Vascular Disease; PAD - Peripheral Arterial Disease
• Interventions: Device: Tennant Biomodulator-Pro™ Device

• Registration Number: NCT04313985
• Lead Sponsor: Stanford University

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.

Detailed Description

Investigators hope to learn if micro-current stimulation to a chronic, non-healing wound can be lead to healing. Perfusion studies and bacterial measurements will be assessed before and after treatment on this cross-over study.

Avazzia microcurrent stimulation was applied to patients with chronic, non-healing wounds in Malaysia and was presented at the international wound conference. In 2015 a poster presentation was presented with a 10-patient case series, and in August 2016, a presentation was made by Dr. Nair, keynote speaker about his 100- patient case series showing that the treatment was safe and effective. Dr. Nair followed this study with a 5-patient study looking at perfusion images using SPY- LUNA imaging equipment. The 5-patient study looked at different methods of applying the therapy.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Results First Submitted: 2023-04-24
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Results First Posted: 2023-06-01
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 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)

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Electrical Stimulation First, then Sham Stimulation	Tennant Biomodulator-Pro™ Device	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.
Sham Electrical Stimulation First, then Electrical Stimulation	Tennant Biomodulator-Pro™ Device	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.

Primary Outcome Measures

Name	Time	Method
Wound Tissue Perfusion	Day 7 of the respective treatment period	To compare wound tissue perfusion following treatment vs placebo (as measured using the HyperMed HyperView device)

Secondary Outcome Measures

Name	Time	Method
Percent Change in Wound Area as a Measure of Healing Rate	Day 7 of the respective treatment period	To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).
Bacterial Biopsies	From time of randomization up until wound healing or 3 weeks, whichever came first	To compare bacterial burden at the wound site following treatment vs placebo (measured in cells per gram of wound tissue from quantitative deep tissue swab)
Pain Score	Day 7 of the respective treatment period	To compare patient pain at the wound site following treatment vs placebo, measured on a numerical 0-10 visual scale (0 = no pain, 10 = worst pain imaginable)

Trial Locations

Locations (1)

Stanford Advanced Wound Care Center; 🇺🇸 Redwood City, California, United States