PACTR202309863893315CompletedPhase 1
The outcome measures of pneumatic compression versus high-frequency vibration on quality of life in diabetic polyneuropathy patients
Not provided0 sites60 target enrollmentStarted: November 21, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 45 Year(s) to 64 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1-Sixty female patients.
- •2- Their ages will range from 50 to 60 years old.
- •3- Their HbA1c is more than 7% and less than 9 %.
- •4- Bilateral lower limb chronic DPN.
- •5- They suffer mild diabetic polyneuropathy for at least three months.
- •6- All the patients have significant decrease in the sensory (sural &superficial peroneal) lower limb nerve conduction velocity (from 20 m/s to 30 m/s).
- •7- All the patients have significant decrease in the motor (tibial &deep peroneal) lower limb nerve conduction velocity (from 20 m/s to 30 m/s).
- •8- All the patients have score more than in 20 Norfolk QOL-DN.
- •9- They all have score more than 8 on Toronto scoring system.
- •10- They have willingness to participate in this study.
Exclusion Criteria
- •1. Chest diseases (either obstructive or restrictive).
- •2. Smoker patient.
- •3. Clinical signs of a severe cardiac event. (eg, congestive heart failure),
- •4. Severe psychiatric or cognitive impairment, who unable to follow comment.
- •5. Neurological disorders affecting respiratory muscles or any muscular dystrophies (cervical disc or bulge).
- •6. Other type of polyneuropathy (Alcoholic, hereditary…..).
- •a) Any patient that suffer from lower limb pathology that may interfere with the results like:
- •b) Cellulitis.
- •c) Lower limb pressure or diabetic ulcer.
- •d) Atherosclerosis.
- •e) Deep venous thrombosis.
Investigators
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