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

Trial Summary

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 data supports the effectiveness of the treatment Peripheral Heating Therapy for improving blood circulation?

Research shows that leg heat therapy can improve perceived physical function and walking ability in patients with peripheral artery disease (PAD), suggesting it may help with blood circulation. In one study, home-based leg heat therapy led to a significant improvement in walking distance, indicating better blood flow. ^{1 2 3 4 5}

Is peripheral heating therapy safe for humans?

Research indicates that peripheral heating therapy, such as leg heat therapy using water-circulating trousers, is safe and well-tolerated in humans, including those with peripheral artery disease. Participants in studies have shown high adherence to the treatment, and no significant safety concerns have been reported. ^{1 2 3 4 6}

How does peripheral heating treatment for blood circulation differ from other treatments?

Peripheral heating treatment is unique because it uses heat applied to the legs to improve blood flow and walking ability, especially in patients with peripheral artery disease (PAD). Unlike other treatments, it is noninvasive, can be done at home using water-circulating trousers, and focuses on increasing blood flow and reducing blood pressure through heat application. ^{1 2 3 7 8}

What is the purpose of this trial?

Blood flow through the popliteal, brachial, and carotid arteries during peripheral heating of the feet

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acute Lower Leg Heating Increases Exercise Capacity in Patients With Peripheral Artery Disease. [2020]

2. United States 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. [2021]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Heated socks maintain toe temperature but not always skin blood flow as mean skin temperature falls. [2022]

5. Germany 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. France pubmed.ncbi.nlm.nih.gov

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

8. United States pubmed.ncbi.nlm.nih.gov

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