Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | 2 tablets BID |
|
| Arm 2 | Experimental | 100 mg Cilostazol (2 tablets BID) |
|
| Arm 3 | Experimental | 200 mg Cilostazol (2 Tablets BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cilostazol | Drug | 100 mg, 200mg tablet Cilostazol |
|
| 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 |
| 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. |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Raymond Rosales, MD, PhD | University of Santo Tomas Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Santo Tomas Hospital | Manila | Philippines |
Not provided
| ID | Term |
|---|---|
| D011115 | Polyneuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |