Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT06101368
Eligibility Criteria:
Inclusion Criteria:
* Patients with Type-II Peripheral Diabetic Neuropathy
* Neuropathy Total Symptom Scale (NTSS-6)\>6
* loss of protective sensation to detect a 10-gram Semmes Weinstein Monofilament on either foot at one of four sites tested or a vibration perception threshold value of 25V or more at either foot's hallux
* Numbness or reduced ability to feel pain or temperature changes.
* Able to Perform 20 minutes per week \>2 bouts of physical activity
* Tingling or burning sensation.
* Sharp pains or cramps.
* Increased sensitivity to touch
* Symptoms last ≥ 6 months
* HbA1c above 6.5% \<12%
* Berg Balance Scale score 45-56
Exclusion Criteria:
* Patients with walking difficulty
* Retinopathy \& poor vision
* Inability to engage in activity without assistance
* Peripheral vascular disease e.g. ABI \<0.6
* orthostatic hypotension, resting heart rate above 100 bpm any Cardiac Issues
* Any diagnosed neuro-psychological issue e.g. depression, dementia or anxiety
* Lower limb amputation,foot deformity or ulceration
* Acute injury
* Hip and Knee OA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
60 Years
Study:
NCT06101368
Study Brief:
Protocol Section:
NCT06101368