CIPN - Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT07583797
TRPM8 Activators for Peripheral Neuropathy
A Phase 2 study testing Hand and Foot Mask in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy (DPN), run by SHIANG-SUO HUANG at 1 site in Taiwan.
Trial summary
The goal of this pilot prospective cohort study is to evaluate the efficacy of a novel hand and foot mask in alleviating symptoms of peripheral neuropathy caused by chemotherapy or diabetes. The study aims to determine whether regular use of these masks can improve patient comfort and quality of life. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- CIPN - Chemotherapy-Induced Peripheral Neuropathy, Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Hand and Foot Mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Nov 2025to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 20 years or older who are currently receiving or have previously received chemotherapy and have clinical features of chemotherapy-induced peripheral neuropathy (CIPN).
- Diabetic patients aged 20 years or older who have clinical features of diabetic peripheral neuropathy (DPN).
- Patients who meet criteria 1 or 2, are willing to participate, and are able to sign an informed consent form.
Who cannot join
- Poorly controlled diabetes (HbA1c > 8%).
- Peripheral vascular disease.
- Chronic kidney disease (eGFR < 30 ml/min/m²).
- Depression, history of surgery on the hands, feet, or back.
- Skin conditions such as leprosy and connective tissue disorders, familial neuropathy.
- Pregnant or breastfeeding women.
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- Individuals with allergic symptoms.
- Individuals with a history of convulsions.
- Individuals with G6PD deficiency (favism).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Innovative TRPM8 Activators Membrane-Based Delivery System on Peripheral Neuropathy
The goal of this pilot prospective cohort study is to evaluate the efficacy of a novel hand and foot mask in alleviating symptoms of peripheral neuropathy caused by chemotherapy or diabetes. The study aims to determine whether regular use of these masks can improve patient comfort and quality of life.
The primary questions this study aims to answer are:
Read more
Does the use of the hand and foot mask reduce the severity of symptoms associated with chemotherapy-induced peripheral neuropathy (CIPN) or diabetic peripheral neuropathy (DPN)?
Does the application of the masks improve patient quality of life and treatment compliance for those undergoing chemotherapy?
Participants will:
Complete an initial assessment questionnaire on Day 1.
Apply hand and foot masks daily for 5 minutes, for 7 consecutive days.
Complete a follow-up questionnaire on Day 7 to assess the effects of one week of use.
Inclusion Criteria
Individuals are eligible for the study if they meet the following criteria:
Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:
Age 20 or older.
Currently receiving or having previously received chemotherapy.
Demonstrating clinical signs and symptoms of chemotherapy-induced peripheral neuropathy.
Diabetic Peripheral Neuropathy (DPN) group:
Age 20 or older.
Diagnosed with diabetes mellitus.
Demonstrating clinical signs and symptoms of diabetic peripheral neuropathy.
General requirement:
Participants must be willing to participate and capable of signing the Informed Consent Form (ICF).
Read the detailed description
Peripheral neuropathy (PN) is a condition characterized by damage or dysfunction of the peripheral nerves, leading to sensory, motor, or autonomic impairments. Symptoms often include numbness, tingling, burning sensations, muscle weakness, and paresthesia. Chemotherapy-induced peripheral neuropathy (CIPN) and diabetic peripheral neuropathy (DPN) are two of the most prevalent causes of PN. Current pharmacological treatments, such as analgesics, anticonvulsants, antidepressants, and opioids, often provide limited efficacy and are frequently associated with significant adverse effects.
Study Rationale and Mechanism of Action:
The "Speedell" hand and foot mask is a novel product formulated to act primarily as a TRPM8 activator. TRPM8 is a non-selective cation channel with six transmembrane domains, widely expressed in human nerve cells. Upon activation by temperatures between 8-28°C or by specific agonists, TRPM8 generates cold signals that are transmitted to the somatosensory cortex.
Scientific literature suggests that the activation of TRPM8-whether by agonists or moderate cooling-induces the release of glutamate at central synapses. This glutamate subsequently activates inhibitory group II/III metabotropic glutamate receptors (mGluRs) located on injured nociceptive afferent neurons or postsynaptic receptors in the dorsal horn, thereby attenuating neuropathic hypersensitivity.
Furthermore, Speedell is designed to deliver natural cooling agents efficiently to the extremities, where they interact with TRPM8 receptors to provide immediate sensory relief. Evidence suggests that these components may contribute to the reduction of tissue damage caused by cellular inflammation. This pilot study aims to clinically validate the efficacy of the Speedell hand and foot mask in alleviating neuropathic discomfort and improving quality of life in patients suffering from chemotherapy-induced or diabetic peripheral neuropathy.
- Being tested
- Hand and Foot Mask
- Keywords
- Peripheral Neuropathy, Chemotherapy, Diabetes, hand and foot mask, CIPN, DPN, TRPM8
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand and Foot MaskCombination product
Daily topical application for 5 minutes over 7 days
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Combination Product: Hand and Foot Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score
The Norfolk QOL-DN is a validated instrument to assess the quality of life in patients with diabetic neuropathy. Scores range from 0 to 4 for each item, where 0 indicates "not at all" and 4 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.
Measured: From baseline (Day 1) to the end of the treatment (Day 7).
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20) Score
The EORTC QLQ-CIPN20 is a specialized module for assessing chemotherapy-induced peripheral neuropathy symptoms. Scores range from 0 to 3 for each item, where 0 indicates "not at all" and 3 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.
Measured: From baseline (Day 1) to the end of the treatment (Day 7).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start3 Nov 2025
- Primary completion7 Apr 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for CIPN - Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group study where all participants receive the intervention. The study design employs a pre- and post-intervention assessment to evaluate changes within the same subjects over the 7-day study period.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SHIANG-SUO HUANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SHIANG-SUO HUANG, Chung Shan Medical University
- Investigators
- Shiang-Suo Huang, PhD, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583797
- Sponsor's protocol ID
- CS2-25059
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wesam S. A., S. A. A., Afnan M. I. K., Amal H. A., Amirah S. A., Areej M. A., Hessa H. A. (2023). Exploring Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Cancer Patients at a Tertiary-Care Hospital: Incidence, Symptoms and Risk Factors. INT J MED RES HEALTH, 17(7), 1-15.
Wang J, Xu W, Wang Q, Yang P, Kan Y, Huang C, Lin F. Efficacy and Safety of Ultrasound-Guided Pulsed Radiofrequency Therapy of Stellate Ganglion on Refractory Painful Diabetic Peripheral Neuropathy. J Pain Res. 2024 Dec 25;17:4521-4531. doi: 10.2147/JPR.S497061. eCollection 2024.
PubMed 39737247Vinik EJ, Hayes RP, Oglesby A, Bastyr E, Barlow P, Ford-Molvik SL, Vinik AI. The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy. Diabetes Technol Ther. 2005 Jun;7(3):497-508. doi: 10.1089/dia.2005.7.497.
PubMed 15929681Rastogi A, Uppula P, Saikia U, Bhansali A. Effect of Monochromatic Infrared Energy on Quality of Life and Intraepidermal Nerve Fiber Density in Painful Diabetic Neuropathy: A Randomized, Sham Control Study. Neurol India. 2021 Sep-Oct;69(5):1331-1337. doi: 10.4103/0028-3886.329614.
PubMed 34747807Ramachandran R, Hyun E, Zhao L, Lapointe TK, Chapman K, Hirota CL, Ghosh S, McKemy DD, Vergnolle N, Beck PL, Altier C, Hollenberg MD. TRPM8 activation attenuates inflammatory responses in mouse models of colitis. Proc Natl Acad Sci U S A. 2013 Apr 30;110(18):7476-81. doi: 10.1073/pnas.1217431110. Epub 2013 Apr 17.
PubMed 23596210Proudfoot CJ, Garry EM, Cottrell DF, Rosie R, Anderson H, Robertson DC, Fleetwood-Walker SM, Mitchell R. Analgesia mediated by the TRPM8 cold receptor in chronic neuropathic pain. Curr Biol. 2006 Aug 22;16(16):1591-605. doi: 10.1016/j.cub.2006.07.061.
PubMed 16920620Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
PubMed 15911236Jensen MP, Gammaitoni AR, Olaleye DO, Oleka N, Nalamachu SR, Galer BS. The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. J Pain. 2006 Nov;7(11):823-32. doi: 10.1016/j.jpain.2006.04.003.
PubMed 17074624Hsieh YL, Chou LW, Hong SF, Chang FC, Tseng SW, Huang CC, Yang CH, Yang CC, Chiu WF. Laser acupuncture attenuates oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: a pilot prospective cohort study. Acupunct Med. 2016 Oct;34(5):398-405. doi: 10.1136/acupmed-2016-011112. Epub 2016 Sep 9.
PubMed 27613370Huang SS, Su HH, Chien SY, Chung HY, Luo ST, Chu YT, Wang YH, MacDonald IJ, Lee HH, Chen YH. Activation of peripheral TRPM8 mitigates ischemic stroke by topically applied menthol. J Neuroinflammation. 2022 Jul 27;19(1):192. doi: 10.1186/s12974-022-02553-4.
PubMed 35897101
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Innovative TRPM8 Activators Membrane-Based Delivery System on Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07583797
- Acronym / sponsor ID
- CS2-25059
- Keywords
- Peripheral Neuropathy, Chemotherapy, Diabetes, hand and foot mask, CIPN, DPN, TRPM8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SHIANG-SUO HUANGUniversity, hospital or other
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot prospective cohort study is to evaluate the efficacy of a novel hand and foot mask in alleviating symptoms of peripheral neuropathy caused by chemotherapy or diabetes. The study aims to determine whether regular use of these masks can improve patient comfort and quality of life.
The primary questions this study aims to answer are:
Does the use of the hand and foot mask reduce the severity of symptoms associated with chemotherapy-induced peripheral neuropathy (CIPN) or diabetic peripheral neuropathy (DPN)?
Does the application of the masks improve patient quality of life and treatment compliance for those undergoing chemotherapy?
Participants will:
Complete an initial assessment questionnaire on Day 1.
Apply hand and foot masks daily for 5 minutes, for 7 consecutive days.
Complete a follow-up questionnaire on Day 7 to assess the effects of one week of use.
Inclusion Criteria
Individuals are eligible for the study if they meet the following criteria:
Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:
Age 20 or older.
Currently receiving or having previously received chemotherapy.
Demonstrating clinical signs and symptoms of chemotherapy-induced peripheral neuropathy.
Diabetic Peripheral Neuropathy (DPN) group:
Age 20 or older.
Diagnosed with diabetes mellitus.
Demonstrating clinical signs and symptoms of diabetic peripheral neuropathy.
General requirement:
Participants must be willing to participate and capable of signing the Informed Consent Form (ICF).
Detailed description
Peripheral neuropathy (PN) is a condition characterized by damage or dysfunction of the peripheral nerves, leading to sensory, motor, or autonomic impairments. Symptoms often include numbness, tingling, burning sensations, muscle weakness, and paresthesia. Chemotherapy-induced peripheral neuropathy (CIPN) and diabetic peripheral neuropathy (DPN) are two of the most prevalent causes of PN. Current pharmacological treatments, such as analgesics, anticonvulsants, antidepressants, and opioids, often provide limited efficacy and are frequently associated with significant adverse effects.
Study Rationale and Mechanism of Action:
The "Speedell" hand and foot mask is a novel product formulated to act primarily as a TRPM8 activator. TRPM8 is a non-selective cation channel with six transmembrane domains, widely expressed in human nerve cells. Upon activation by temperatures between 8-28°C or by specific agonists, TRPM8 generates cold signals that are transmitted to the somatosensory cortex.
Scientific literature suggests that the activation of TRPM8-whether by agonists or moderate cooling-induces the release of glutamate at central synapses. This glutamate subsequently activates inhibitory group II/III metabotropic glutamate receptors (mGluRs) located on injured nociceptive afferent neurons or postsynaptic receptors in the dorsal horn, thereby attenuating neuropathic hypersensitivity.
Furthermore, Speedell is designed to deliver natural cooling agents efficiently to the extremities, where they interact with TRPM8 receptors to provide immediate sensory relief. Evidence suggests that these components may contribute to the reduction of tissue damage caused by cellular inflammation. This pilot study aims to clinically validate the efficacy of the Speedell hand and foot mask in alleviating neuropathic discomfort and improving quality of life in patients suffering from chemotherapy-induced or diabetic peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group study where all participants receive the intervention. The study design employs a pre- and post-intervention assessment to evaluate changes within the same subjects over the 7-day study period.
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Combination Product: Hand and Foot Mask |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 20 years or older who are currently receiving or have previously received chemotherapy and have clinical features of chemotherapy-induced peripheral neuropathy (CIPN).
- Diabetic patients aged 20 years or older who have clinical features of diabetic peripheral neuropathy (DPN).
- Patients who meet criteria 1 or 2, are willing to participate, and are able to sign an informed consent form.
Key exclusion criteria (9 listed)
- Poorly controlled diabetes (HbA1c > 8%).
- Peripheral vascular disease.
- Chronic kidney disease (eGFR < 30 ml/min/m²).
- Depression, history of surgery on the hands, feet, or back.
- Skin conditions such as leprosy and connective tissue disorders, familial neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand and Foot MaskDaily topical application for 5 minutes over 7 days | Combination product | treatment |
Primary outcome
Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score
Time frame: From baseline (Day 1) to the end of the treatment (Day 7).
The Norfolk QOL-DN is a validated instrument to assess the quality of life in patients with diabetic neuropathy. Scores range from 0 to 4 for each item, where 0 indicates "not at all" and 4 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CIPN20) Score
Time frame: From baseline (Day 1) to the end of the treatment (Day 7).
The EORTC QLQ-CIPN20 is a specialized module for assessing chemotherapy-induced peripheral neuropathy symptoms. Scores range from 0 to 3 for each item, where 0 indicates "not at all" and 3 indicates "very much." A change in the total score will be calculated to measure the impact of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- BackgroundWesam S. A., S. A. A., Afnan M. I. K., Amal H. A., Amirah S. A., Areej M. A., Hessa H. A. (2023). Exploring Chemotherapy-Induced Peripheral Neuropathy (CIPN) in Cancer Patients at a Tertiary-Care Hospital: Incidence, Symptoms and Risk Factors. INT J MED RES HEALTH, 17(7), 1-15.
- Background: PubMed 39737247Wang J, Xu W, Wang Q, Yang P, Kan Y, Huang C, Lin F. Efficacy and Safety of Ultrasound-Guided Pulsed Radiofrequency Therapy of Stellate Ganglion on Refractory Painful Diabetic Peripheral Neuropathy. J Pain Res. 2024 Dec 25;17:4521-4531. doi: 10.2147/JPR.S497061. eCollection 2024.
- Background: PubMed 15929681Vinik EJ, Hayes RP, Oglesby A, Bastyr E, Barlow P, Ford-Molvik SL, Vinik AI. The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy. Diabetes Technol Ther. 2005 Jun;7(3):497-508. doi: 10.1089/dia.2005.7.497.
- Background: PubMed 34747807Rastogi A, Uppula P, Saikia U, Bhansali A. Effect of Monochromatic Infrared Energy on Quality of Life and Intraepidermal Nerve Fiber Density in Painful Diabetic Neuropathy: A Randomized, Sham Control Study. Neurol India. 2021 Sep-Oct;69(5):1331-1337. doi: 10.4103/0028-3886.329614.
- Background: PubMed 23596210Ramachandran R, Hyun E, Zhao L, Lapointe TK, Chapman K, Hirota CL, Ghosh S, McKemy DD, Vergnolle N, Beck PL, Altier C, Hollenberg MD. TRPM8 activation attenuates inflammatory responses in mouse models of colitis. Proc Natl Acad Sci U S A. 2013 Apr 30;110(18):7476-81. doi: 10.1073/pnas.1217431110. Epub 2013 Apr 17.
- Background: PubMed 16920620Proudfoot CJ, Garry EM, Cottrell DF, Rosie R, Anderson H, Robertson DC, Fleetwood-Walker SM, Mitchell R. Analgesia mediated by the TRPM8 cold receptor in chronic neuropathic pain. Curr Biol. 2006 Aug 22;16(16):1591-605. doi: 10.1016/j.cub.2006.07.061.
- Background: PubMed 15911236Postma TJ, Aaronson NK, Heimans JJ, Muller MJ, Hildebrand JG, Delattre JY, Hoang-Xuan K, Lanteri-Minet M, Grant R, Huddart R, Moynihan C, Maher J, Lucey R; EORTC Quality of Life Group. The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: the QLQ-CIPN20. Eur J Cancer. 2005 May;41(8):1135-9. doi: 10.1016/j.ejca.2005.02.012. Epub 2005 Apr 14.
- Background: PubMed 17074624Jensen MP, Gammaitoni AR, Olaleye DO, Oleka N, Nalamachu SR, Galer BS. The pain quality assessment scale: assessment of pain quality in carpal tunnel syndrome. J Pain. 2006 Nov;7(11):823-32. doi: 10.1016/j.jpain.2006.04.003.
- Background: PubMed 27613370Hsieh YL, Chou LW, Hong SF, Chang FC, Tseng SW, Huang CC, Yang CH, Yang CC, Chiu WF. Laser acupuncture attenuates oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer: a pilot prospective cohort study. Acupunct Med. 2016 Oct;34(5):398-405. doi: 10.1136/acupmed-2016-011112. Epub 2016 Sep 9.
- Background: PubMed 35897101Huang SS, Su HH, Chien SY, Chung HY, Luo ST, Chu YT, Wang YH, MacDonald IJ, Lee HH, Chen YH. Activation of peripheral TRPM8 mitigates ischemic stroke by topically applied menthol. J Neuroinflammation. 2022 Jul 27;19(1):192. doi: 10.1186/s12974-022-02553-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiang-Suo Huang, PhD principal investigator
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hand and Foot Mask in people with CIPN - Chemotherapy-Induced Peripheral Neuropathy and Diabetic Peripheral Neuropathy (DPN), run by SHIANG-SUO HUANG at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) Score (time frame: From baseline (Day 1) to the end of the treatment (Day 7).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583797, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.