Chocolate Touch for Ischemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lankenau Medical Center, Wynnewood, PA
Ischemia+1 More
Chocolate Touch - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a device that delivers a small amount of chocolate to the skin can improve blood flow in the legs.

See full description

Eligible Conditions

  • Ischemia
  • Intermittent Claudication

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Chocolate Touch will improve 2 primary outcomes and 3 secondary outcomes in patients with Ischemia. Measurement will happen over the course of 1 hour.

1 hour
By Angiographic Core Lab Review (Acute)
Month 24
By Clinical Assessment
12 months
Freedom from Major Adverse Events
True Drug Coated Balloon Success
Month 24
By Duplex Ultrasound Core Lab Review

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group (Lutonix Drug Coated Balloon)
1 of 2
Test Group (Chocolate Touch)
1 of 2
Active Control
Experimental Treatment

This trial requires 585 total participants across 2 different treatment groups

This trial involves 2 different treatments. Chocolate Touch is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Test Group (Chocolate Touch)
Device
The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1. The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome. If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation.
Control Group (Lutonix Drug Coated Balloon)
Device
Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion. The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of >1:1). If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit. Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1, 6, 12, & 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1, 6, 12, & 24 months for reporting.

Closest Location

Lankenau Medical Center - Wynnewood, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Minimum of 18 years of age
Intermittent claudication or ischemic rest pain (Rutherford 2-4)
Life Expectancy >2 years
Patient has agreed to follow-up requirements and given informed consent
Lesion successfully crossed with a guidewire
Lesion in the superficial femoral or popliteal artery
Target lesion >70% stenosis
Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
Target Lesion <18cm that consists of no more than two adjacent lesions (<25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons
Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle

Patient Q&A Section

Can intermittent claudication be cured?

"Patients with intermittent claudication can be successfully treated. The condition can be improved to the level that they will go on to walk without help. Although the condition of their hips may also have improved, patients continue to have chronic pain and an associated degree of activity restriction." - Anonymous Online Contributor

Unverified Answer

What are common treatments for intermittent claudication?

"Intermittent claudication is rarely relieved by surgery. Painkillers are sometimes effective but are generally not recommended as the sole treatment for the condition. Low-level exercise (e.g., walking or swimming) can help improve the condition in the short-term, but is less effective than a short duration of inelastic bandaging." - Anonymous Online Contributor

Unverified Answer

How many people get intermittent claudication a year in the United States?

"Around 380,000 people in the United States are diagnosed with intermittent claudication. There are around 3.6 million new cases a year. This article is based on a review of the literature and excludes cases in early stage." - Anonymous Online Contributor

Unverified Answer

What causes intermittent claudication?

"Current data provide little information regarding the cause of intermittent claudication. The possibility of significant atherosclerosis in the claudication area could be considered, but this needs to be confirmed. In patients with severe claudication, atherosclerosis should be excluded after careful workup to rule out the possibility of renal artery stenosis causing intermittent claudication, although it may also be a common cause of intermittent claudication in the elderly. The most common cause of intermittent claudication in this age group remains hypertension." - Anonymous Online Contributor

Unverified Answer

What is intermittent claudication?

"Intermittent claudication is a walking-related complication of peripheral arterial disease with a variable clinical and morphologic presentation that may be more common than currently appreciated." - Anonymous Online Contributor

Unverified Answer

What are the signs of intermittent claudication?

"Intermittent claudication is an incidental finding on medical examination. It is an uncommon presentation but may be suggestive of other causes. The diagnostic procedure is simple and the results are of great clinical value." - Anonymous Online Contributor

Unverified Answer

Has chocolate touch proven to be more effective than a placebo?

"Chocolates may have a beneficial effect on treadmill walking in women with chronic intermittent claudication, as reported in observational studies. The effect may be partly mediated by the antioxidative properties of the polyphenols in cocoa and chocolate products. Further studies are needed to determine whether chocolate and cocoa products can be a therapeutic option for the management of claudication and to study the mechanisms of action." - Anonymous Online Contributor

Unverified Answer

What does chocolate touch usually treat?

"Even though patients report a significant improvement in chest pain and exercise tolerance after consuming chocolate, there is not high-quality evidence linking chocolate consumption and chest pain. We therefore conclude that more research is needed to determine if eating chocolate decreases, increases, or does not affect PAD." - Anonymous Online Contributor

Unverified Answer

Is chocolate touch typically used in combination with any other treatments?

"This survey showed high chocolate touch use with intermittent claudication (67.4%). If patients have tried any other treatment types used in combination with chocolate touch, see the table. If patients have never heard of, or never tried any treatment used in combination with chocolate touch, see the table." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating intermittent claudication?

"No significant advances in treatments were identified in our review. More studies are necessary to confirm safety and effectiveness of the treatments, with emphasis on new or alternative therapies, and to optimize pharmacotherapy for all patients with disabling intermittent claudication." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in chocolate touch for therapeutic use?

"The latest developments in chocolate touch involve improving the consistency of the product's chocolate coating, which in turn results in a better shelf life and, therefore, greater compliance with therapy." - Anonymous Online Contributor

Unverified Answer

What is chocolate touch?

"The concept of chocolate touch is not based on a scientific rationale, neither is it a therapeutic practice or a scientific basis to explain the clinical manifestation. A scientific rationale needs to be clearly provided and evidence-based. There is no conclusive evidence of the safety and efficacy of chocolate touch. Based on the current evidence, this practice should be avoided." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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