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10.6-µm Infrared Laser as Adjuvant Therapy for Diabetic Peripheral Neuropathy: a Double-Blind, Randomized Controlled Trial

10.6-µm Infrared Laser as Adjuvant Therapy for Diabetic Peripheral Neuropathy: a Double-Blind, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002935
Enrollment
Unknown
Registered
2020-01-25
Start date
2020-02-17
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral Neuropathy

Interventions

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) diagnosed with DPN in both lower extremities; (2) aged 18–75 years old, no limit on gender; (3) delayed nerve conduction velocity in lower extremities; (4) stable levels of blood glucose level (FPG <= 7.0 mmol/L2hPBG <= 8 mmol/LHbA1c <= 7%); (5) understanding and signing the informed consent.

Exclusion criteria

Exclusion criteria: (1) neuropathy or chronic pain caused by conditions other than diabetes; (2) DPN most prevalent in the upper limbs; (3) Presence of serious medical conditions, including kidney diseases, heart diseases, pulmonary diseases, liver diseases or contagious diseases, or malignant tumors and serious psychopathy; (4) Previous history of knee/hip replacement surgery or bone fracture of the lower extremities during the last 3 months and other conditions that would confound assessment of neuropathy; (5) Ulceration and other diseases at the lower extremities; (6) Acupuncture or moxibustion treatment received in the previous 3 months; (7) LLLT received in the previous 3 months; (8) Using other external therapy simultaneously; (9) Opiate, analgesic, illicit drug or alcohol abuse; (10) Unwillingness to be randomly assigned into either a treatment or a placebo group; (11) Unable to fill measurement questionnaires; (12) Recruited in other clinical trial simultaneously; (13) Pregnant or breast-feeding women.

Design outcomes

Primary

MeasureTime frame
Nerve Conduction Velocity;

Secondary

MeasureTime frame
Michigan Neuropathy Screening Instrument;

Countries

China

Contacts

Public ContactXueyong Shen

Shanghai University of Traditional Chinese Medicine

snowysh@hotmail.com+86 02151322173

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026