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A randomized controlled study of acid fibroblast growth factor combined with neurolysis in the treatment of DPN

A randomized controlled study of acid fibroblast growth factor combined with neurolysis in the treatment of DPN

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035565
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-17

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

Conditions

diabetic foot

Interventions

Trial group:Neurolysis combined with acid fibroblast growth factor treatment
control group:simple neurolysis treatment

Sponsors

Affiliated Hospital of Zunyi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18-80 years old patients, both male and female; 2. The patients who met the diagnostic criteria of type 2 diabetes mellitus (according to the 1999 who diagnostic criteria for diabetes): diabetes symptoms plus plasma glucose >= 11.1mmol/l (200mg / dl), fasting plasma glucose level (FPG) >= 7.0mmol/l (126mg / dl), or 2-hour blood glucose (2hPG) >= 11.1mmol/l (200mg / dl) in oral glucose tolerance test (OGTT). The diagnosis can be established only after repeated confirmation; 3. Patients who met the diagnostic criteria of DPN (according to the 2010 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus); (1) Have a clear history of diabetes, or have diabetes confirmed by laboratory examination of diabetes mellitus; (2) Neuropathy at or after the diagnosis of diabetes mellitus; (3) Clinical symptoms and signs were consistent with DPN, such as persistent paresthesia or pain in the limbs (at least both lower limbs); (4) DPN can be diagnosed if any one of the following four examinations is abnormal: abnormal ankle or knee reflex; abnormal acupuncture pain; abnormal vibration sense; abnormal pressure sense. Except for peripheral neuropathy caused by other reasons, such as cerebral infarction, Guillain Barre syndrome, cervical and lumbar lesions (spinal canal stenosis, nerve root compression, cervical and lumbar degenerative changes), severe arteriovenous vascular diseases (venous embolism, lymphangitis), etc., it is necessary to identify the neurotoxic effects caused by chemotherapy drugs and metabolic toxicants caused by renal insufficiency The damage. If the diagnosis can not be made according to the above examination, the patients who need to be differentiated can be examined by neuroelectromyography. 4. Patients without serious complications and other serious diseases, no absolute contraindication of operation; 5. Patients who knew and voluntarily participated in the study; 6. Patients with positive percussion sign of common peroneal nerve and tibial nerve; 7. Patients with abnormal common peroneal nerve and tibial nerve evoked potential.

Exclusion criteria

Exclusion criteria: 1. Patients with nerve root compression, spinal canal stenosis, cervical and lumbar degenerative degeneration and other diseases that can cause peripheral neuropathy; 2. Patients with arteriovenous vascular diseases such as venous embolism and lymphangitis; 3. Patients with stroke and Guillain Barre syndrome; 4. Patients with severe dysfunction of heart, lung, liver and kidney; 5. Patients with chronic diabetic complications other than DPN, and acute complications of diabetes, such as diabetic hyperosmolar coma, diabetic ketosis and ketoacidosis, lactic acidosis, etc.; patients with malignant tumor; pregnant women or lactating women.

Design outcomes

Primary

MeasureTime frame
Quantitative sensory testing;Toronto Clinical Neuropathy Scale;Visual simulation scoring system;

Secondary

MeasureTime frame
Neuroelectrophysiological examination;Knee and ankle reflections;

Countries

China

Contacts

Public ContactWei Zairong

Department of Burn and Plastic Surgery, Affiliated Hospital of Zunyi Medical University

188116999@qq.com+86 15208660008

Outcome results

None listed

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