Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines

Study Overview
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Brief Summary
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To describe if there are differences in the subjective, objective and electrophysiologic parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and twelve (12) weeks after Cilostazol therapy.

Conditions
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Polyneuropathy

Intervention / Treatment
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* Drug: Cilostazol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Signed written informed consent 2. Male and Female ages 18 to 70 years old. To be able to eliminate Type I Diabetes Mellitus among the younger subjects, we will only recruit patients who are stable on oral hypoglycemic agent. 3. Established diagnosis of diabetes mellitus type 2 (National Diabetes Data Group) who are currently on good control of the diabetic state. 4. Presence of predominantly distal symmetrical sensory polyneuropathy of the lower limbs as assessed by NSS, NIS and NCS. Exclusion Criteria: Current use of potentially neuropathic agents (Isoniazid, Phenytoin, Dapsone, Metronidazole, Vinca Alkaloids, etc.) within the past 1 month; Presence of severe metabolic disease (renal failure, hepatic failure, etc.), alcoholism and malignancy; Presence of hemorrhagic tendencies; Patients who are diagnosed to be of Type 1 Diabetes Mellitus; Pregnant and lactating patients, including those who plan to have pregnancy within the study period. Concomitant intake of agents currently used to treat neuropathic pain like gabapentin, carbamazepine/ oxcarbazepine, anti-depressants (tricyclic anti-depressants and SSRIs) and topical capsaicin. Concomitant intake of other anti-platelet agents, rheologic agents and anticoagulants. Have received Cilostazol therapy within the past three (3) months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 1<br>2 tablets BID | Drug: Cilostazol<br>* 100 mg, 200mg tablet Cilostazol<br>* Other names: Cilostazol, Pletaal, Pletal;|
| Experimental: Arm 2<br>100 mg Cilostazol (2 tablets BID) | Drug: Cilostazol<br>* 100 mg, 200mg tablet Cilostazol<br>* Other names: Cilostazol, Pletaal, Pletal;|
| Experimental: Arm 3<br>200 mg Cilostazol (2 Tablets BID) | Drug: Cilostazol<br>* 100 mg, 200mg tablet Cilostazol<br>* Other names: Cilostazol, Pletaal, Pletal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective neuropathy assessment by NSS (Neuropathy Symptom Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. |  | 12 weeks | 
| Objective neuropathy assessment by NIS (Neuropathy Impairment Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. |  | 12 weeks | 
| Electrophysiologic assessment by NCS (Nerve Conduction Studies) from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. |  | 12 weeks | 
| To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is improvement in subjective parameters of neuropathy as assessed by NSS and NSC (Neuropathy Symptoms and Change Questionnaire) from baseline to week 4 (W4), week 8 (W8) and week 12 (W12) after Cilostazol therapy. |  | 12 weeks | 
| To determine if there is improvement in objective parameters using NIS and NCS from baseline to W4, W8 and W12 after Cilostazol therapy. |  | 12 weeks | 
| To compare the effectivity of low dose (100mg) and high dose (200mg) Cilostazol based on subjective (NSS, NSC) and objective parameters (NIS, NCS) from baseline, to W4, W8 and W12. |  | 12 weeks | 
| To assess the safety of Cilostazol therapy. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symmetric Diabetic Polyneuropathy