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NCT07841730
Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer
Conditions: Diabetic Foot
Sex: All
Ages: 55 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 38
Sponsor: University of Lahore
Summary
The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 55-75 years
* Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
* Both male and female participants.
* Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
* Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
* Patient with healed ulcer or in last stage of healing duration \>1 to 2 weeks
* Absence of active infection.
* No cognitive impairments that would affect participation.
* Diabetes duration of less than 10 years.
* Able to perform the exercises and participate in physical therapy sessions.
* No history of amputation above the metatarsophalangeal joint.
Exclusion Criteria:
* Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
* Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
* Recent fractures, or trauma leading to nerve injuries in the last year.
* Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
* Visual impairments or cognitive disorders that could affect participation.
* History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
* Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
* Pregnancy or unwillingness to participate.
Source: ClinicalTrials.gov (NCT07841730). StuddyBuddy aggregates publicly available trial information.