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

PAD - Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04313985
• Other study ID #: 45628
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• PAD - Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• PVD- Peripheral Vascular Disease
• Vascular Diseases

Intervention

Device:
• Tennant Biomodulator-Pro™ 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.

Locations

Country	Name	City	State
United States	Stanford Advanced Wound Care Center	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent Change in Wound Area as a Measure of Healing Rate	To compare rate of wound healing following treatment vs placebo (measured as percentage change in wound area).	Day 7 of the respective treatment period
Secondary	Bacterial Biopsies	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)	From time of randomization up until wound healing or 3 weeks, whichever came first
Secondary	Pain Score	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)	Day 7 of the respective treatment period