Peripheral Heating for Blood Circulation

Overseen By Jeff Moore, M.S./M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: San Diego State University

Disqualifiers: Open wounds on feet or legs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how heating the feet can improve blood flow in certain arteries, which carry blood from the heart to the rest of the body. Participants will either have both feet gently heated (peripheral heating of two feet) or join a comparison group without heating. The trial is designed for individuals without open wounds on their feet or legs. Those with healthy feet who are curious about how heat affects circulation might be a good fit for this study. As an unphased study, it offers a unique opportunity to contribute to scientific understanding of circulation and potentially benefit from improved blood flow.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that peripheral heating of the feet is safe?

Research has shown that heat therapy, such as warming the legs or feet, is generally safe and well-tolerated. One study found that using special pants to heat the legs at home was safe and improved walking ability. Another study demonstrated that heating the legs for 90 minutes lowered blood pressure and enhanced blood flow in a major leg artery. A review of several studies also noted increased blood flow in the limbs due to heat therapy.

These findings suggest that warming the feet or legs is unlikely to cause serious problems and might improve circulation. However, following guidelines and consulting healthcare providers about any concerns is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about peripheral heating for improving blood circulation because it's a non-invasive technique that could enhance blood flow without medication. Unlike standard treatments that often involve drugs to improve circulation, this method uses heat applied to the feet, which may boost blood flow naturally. This approach could offer a simple and drug-free alternative, reducing the side effects associated with medications. Additionally, the ease of use and potential for at-home application make it a promising option for many patients.

What evidence suggests that peripheral heating of the feet is effective for improving blood circulation?

This trial will compare the effects of peripheral heating of both feet with a sham treatment. Research has shown that warming the legs can improve blood flow and reduce blood pressure. One study found that heating the legs increased blood flow in the artery behind the knee. Another study showed that using leg heat therapy for 90 minutes significantly increased blood flow and lowered blood pressure. Overall, these findings suggest that warming the feet can enhance circulation, potentially benefiting blood flow in key arteries in the legs, arms, and neck. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged between 18 and 65 who want to help study blood circulation. It's not suitable for people with open wounds on their feet or legs.

Exclusion Criteria

I have open wounds on my feet or legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Blood flow is measured during peripheral heating of the feet

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Peripheral heating of 2 feet
• Sham

Trial Overview The study tests how blood flow in the arteries of the leg, arm, and neck changes when the feet are heated up. Some participants will have actual heating (intervention) while others will undergo a pretend treatment (sham).

How Is the Trial Designed?

Group I: Two feet Experimental Treatment 1 Intervention

Blood flow during heating of two feet

Group II: Sham Placebo Group 1 Intervention

Blood flow without heating

Who Is Running the Clinical Trial?

San Diego State University

Lead Sponsor

Trials

182

Recruited

119,000+

Published Research Related to This Trial

A case study of a 60-year-old woman with type 2 diabetes showed that temperature biofeedback (TBFB) applied to the toe improved her ankle-brachial index and walking function after five sessions, indicating enhanced vascular flow.

The study suggests that TBFB can effectively increase toe temperature and blood flow in patients with diabetes, but further controlled studies are needed to confirm its benefits for vascular and walking improvements in diabetic claudication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal biofeedback for claudication in diabetes: a literature review and case study. Aikens, JE.[2009]

A pilot study involving 34 patients with symptomatic peripheral artery disease (PAD) found that unsupervised, home-based leg heat therapy significantly improved walking performance, with a notable increase in the 6-minute walk distance after 8 weeks compared to a sham treatment.

The leg heat therapy was shown to be safe and well-tolerated, suggesting it could be a practical and painless adjunctive treatment to enhance physical function in patients with PAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home-based leg heat therapy on walking performance in patients with symptomatic peripheral artery disease: a pilot randomized trial. Monroe, JC., Pae, BJ., Kargl, C., et al.[2023]

In a pilot study involving 6 patients with peripheral artery disease (PAD), acute lower leg heating significantly increased blood flow in the popliteal artery, demonstrating a duration-dependent effect after treatment.

The 6-minute walk distance improved by 10% and 12% following 15 and 45 minutes of heating, respectively, indicating that even short heating sessions can enhance exercise capacity in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. Pellinger, TK., Neighbors, CB., Simmons, GH.[2020]

A 6-week supervised leg heat therapy (HT) using water-circulating trousers did not improve walking distance or blood pressure in patients with peripheral artery disease (PAD), but it significantly enhanced perceived physical function and reduced serum endothelin-1 levels.

The study involved 32 PAD patients, with 30 completing the treatment, showing high adherence and good tolerance to HT, indicating its potential as a supportive therapy for improving quality of life in PAD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg heat therapy improves perceived physical function but does not enhance walking capacity or vascular function in patients with peripheral artery disease. Monroe, JC., Lin, C., Perkins, SM., et al.[2021]

A study involving 40 diabetic subjects demonstrated that relaxation training combined with thermal biofeedback significantly improved toe temperatures and blood circulation in the lower extremities, with temperature increases of 31.38% and blood volume pulse increases of 22.47% after the intervention.

The relaxation technique accounted for 71% of the increase in blood volume pulse, suggesting that this noninvasive method could be an effective adjunct treatment for improving blood flow in diabetic patients with circulation issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of thermal biofeedback-assisted relaxation training on blood circulation in the lower extremities of a population with diabetes. Rice, BI., Schindler, JV.[2019]

In a study with four male subjects exposed to cold air at 4 degrees C, heated socks were able to keep foot skin temperature above 37 degrees C, but did not consistently maintain toe skin blood flow (Q(toe)) in two of the subjects.

The results suggest that heated socks are not a reliable method for preventing non-freezing cold injuries during extended exposure to cold environments, highlighting the need for better protective measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heated socks maintain toe temperature but not always skin blood flow as mean skin temperature falls. House, CM., Lloyd, K., House, JR.[2022]

The manudouche and pedidouche techniques were tested on over 200 patients to treat various peripheral circulation diseases, showing promise in relieving vascular spasms and reducing sympathetic excitability.

The study suggests that these thermal treatments are effective for peripheral circulatory diseases and calls for a review of thermal treatment classifications for vascular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experimental monitoring of the effects of hand and foot douches at Barbotan on peripheral circulation]. Garreau, C.[2008]

In a study involving 13 young females, eight weeks of single leg heating did not improve endothelial function in the lower limbs, as measured by various flow-mediated dilation tests.

These findings contrast with previous research that indicated limb heating could enhance endothelial function in the upper limbs, suggesting that the effects of heating may differ between body regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of repeated, local heating-induced increases in blood flow on lower limb endothelial function in young, healthy females. McGarity-Shipley, EC., Schmitter, SM., Williams, JS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7792848/

Leg heat therapy improves perceived physical function but ... A single session of leg heat therapy (HT) has been shown to elicit increases in leg blood flow and reduce blood pressure (BP) and the circulating levels of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468428724002600

Development and feasibility testing of a new device for ... Exposure to leg HT for 90 minutes using water-circulating trousers resulted in a significant decrease in blood pressure and a substantial increase in popliteal ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03763357

Acute Effects of Leg Heating on Skeletal Muscle Blood Flow The objective of this study is to test the hypothesis that a single session of heat therapy will increase local muscle tissue blood flow in the calf of patients ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8358540/

A systematic review of the role of heat therapy for patients ... Results suggest that whole-body immersion and a lower-body heated garment increased limb blood flow. Pellinger et al. and Thomas et al. reported that blood flow ...

5. journals.physiology.org journals.physiology.org/doi/10.1152/japplphysiol.00977.2024

Home-based heat therapy lowers blood pressure and ... This study determined that 8 wk of home-based lower body heat therapy reduced ambulatory daytime systolic blood pressure and increased flow-mediated dilation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9448284/

Effects of home-based leg heat therapy on walking ... We demonstrate that unsupervised HT using water-circulating trousers is safe, well-tolerated, and elicits meaningful changes in walking ability in patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05465070

Leg Heat Therapy in Peripheral Artery Disease Secondary outcomes include changes in the short physical performance battery score, handgrip strength, quality of life (measured by the Walking Impairment ...