Peripheral Arterial Disease Trial, Recruiting NCT06567795 Sponsor: Aventusoft, LLC. Condition: Peripheral Arterial Disease
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Peripheral Arterial Disease Trial, Recruiting

NCT06567795
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are over 40 years old
  • You have been diagnosed with Type 2 Diabetes (whether or not you use insulin) for at least 5 years
  • You have been diagnosed with a heart or blood vessel disease (such as heart disease, stroke-related disease, or poor circulation in the legs) — OR — you have at least one of the following: diabetic eye disease, diabetic kidney disease, diabetic nerve damage, or elevated levels of a specific inflammation marker in your blood (hs-CRP), AND also have two or more of the following: high blood pressure for at least 6 months, high cholesterol, a body weight above a certain threshold (BMI ≥27 for men or ≥22 for women), or a history of smoking (confirm with trial site for exact details)
  • You are willing to undergo evaluations using a device called HEMOTAG
  • You are willing to attend standard medical check-up visits and have a specific blood test (NT-pro BNP) done
  • You are willing to use the HEMOTAG device at home at least three days per week during certain 30-day periods throughout the study
  • You are willing to send and receive the HEMOTAG kit by post at required times during the study
  • You are able to give your informed consent to participate

Who may not be able to join:

  • You have a serious illness where your life expectancy is less than 12 months
  • You have a physical deformity or wound on your chest area that could prevent the HEMOTAG device from being applied properly
  • You have a skin condition or sensitivity that could be made worse or cause significant discomfort by wearing skin electrodes
  • You are currently enrolled in another interventional clinical trial (being part of an observational study or registry is acceptable)
  • You are a prisoner or ward of the state
  • You have a cognitive (thinking or memory) difficulty or other condition that may prevent you from fully following the study requirements, as judged by the study doctor
  • You are not able to make a fully informed and voluntary decision to participate on your own (studies requiring a legal representative to provide consent are not eligible)
  • You are not able to communicate in English
  • You are pregnant or planning to become pregnant during the study
  • You are a woman of childbearing potential who is unwilling or unable to use contraception during the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 954-399-3335

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Aventusoft, LLC.
Registry
ClinicalTrials.gov
Start date
14 March 2024
Est. completion
18 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov