DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02145988
• Date of registration: 21/05/2014
• Prospective Registration: Yes
• Primary sponsor: Dexa Medica Group
• Public title: DLBS1033 Treatment in Diabetic With Peripheral Arterial Disease
• Scientific title: Improvement of Ankle-Brachial Index by DLBS1033 Treatment in Diabetic Patients With Peripheral Arterial Disease
• Date of first enrolment: June 3, 2015
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02145988
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Indonesia

Contacts

• Name: Ketut Suastika, Prof, SpPD, MD
• Affiliation: Department of Internal Medicine, Faculty of Medicine, University of Udayana/Sanglah Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Signed informed consent before any trial related activities.

- Male or female subjects of 40 - 65 years of age.

- Diagnosis of diabetes mellitus defined as HbA1c level of = 6.5% (for newly diagnosed
diabetes) or based on medical history.

- Presence of peripheral arterial disease with resting ankle-brachial index (ABI) of
0.41-0.90 inclusive

Exclusion Criteria:

- Females of childbearing potential: pregnancy, breast-feeding, and the intention of
becoming pregnant.

- Recent stroke attack, myocardial infarction/unstable angina/acute coronary syndrome,
coronary artery bypass surgery (CABG) or percutaneous transluminal coronary
angioplasty (PTCA)/stent within 3 (three) months prior to screening.

- Impaired liver function: serum ALT > 2.5 times upper limit of normal.

- Impaired renal function: serum creatinine = 1.5 times upper limit of normal.

- Concomitant use of other antithrombosis drugs or any antiplatelets other than the
study medication.

- Subjects with concurrent herbal (alternative) medicines or food supplements

- Subjects with any other disease state, including chronic or acute systemic infections,
uncontrolled illnesses or other chronic diseases, which judged by the investigator,
could interfere with trial participation or trial evaluation.

- Subjects with high risk of bleeding:

- Subjects with prior experience with DLBS1033 or other oral lumbrokinase products.

- Subjects with known or suspected allergy to any of study medications used in the
study, including other lumbrokinase products.

- Subjects with known or suspected allergy or resistant to aspirin.



Age minimum: 40 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Diabetes

Intervention(s)

Drug: Placebo

Drug: DLBS1033

Primary Outcome(s)

Resting ankle-brachial index (ABI) [Time Frame: Week 0 and 12]

Secondary Outcome(s)

hs-CRP [Time Frame: Week 0, 6, and 12]

Adverse events [Time Frame: Week 0 - 12]

Haemostasis parameters [Time Frame: Week 0, 6, and 12]

d-dimer [Time Frame: Week 0, 6, and 12]

Resting ABI [Time Frame: Week 0 and 6]

Routine hematology [Time Frame: Week 0, 6, and 12]

Thromboxane B2 [Time Frame: Week 0, 6, and 12]

Fibrinogen [Time Frame: Week 0, 6, and 12]

Liver function [Time Frame: Week 0 and 12]

Renal function [Time Frame: Week 0 and 12]

Secondary ID(s)

DLBS1033-0312

Source(s) of Monetary Support

Please refer to primary and secondary sponsors