Treatment of Diabetic Foot Ulcers With AUP1602-C
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|ClinicalTrials.gov Identifier: NCT04281992|
Recruitment Status : Recruiting
First Posted : February 24, 2020
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Biological: AUP1602-C||Phase 1 Phase 2|
Study AP-W-CLI-2018-8 is the first clinical study of AUP1602-C in humans. It is a Phase 1/2A clinical study to evaluate the safety, tolerability and efficacy of a single and repeated doses of AUP-16 as topical treatment of DFU. The Phase 1 part will be a multicenter, open-label, non-randomized, uncontrolled dose-finding study with sequential dose escalations performed in dose cohorts comparing three doses of AUP-16 administered three times per week (low, medium, and high dose cohorts). This part will consist of four sequentially recruited cohorts. It is expected that a minimum of 15 patients may be required to determine the RP2D in phase 1 part.
The Phase 2A part, an extension of the Phase 1, will be a multi-center, open-label, randomized, placebo-controlled study of the recommended AUP1602-C dose and administration schedule from Phase 1 to confirm safety and to assess efficacy of the selected recommended phase 2 dose and schedule in DFU patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Analyses for phase 1 part will be done by cohort and analyses for phase 2A part will be done by treatment arms.|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1/2A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Single and Repeated Doses of AUP1602-C as Topical Treatment of Diabetic Foot Ulcers|
|Actual Study Start Date :||January 28, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||November 30, 2021|
AUP1602-C will be administered topically once or repeatedly three times per week during the treatment period.
AUP1602-C is topically applied on chronic wounds and covered by wound dressing.
- Incidence of adverse events (AEs) and potential dose-limiting toxicities (DLTs) [ Time Frame: 4 weeks ]Incidence of adverse events (AEs) and potential dose-limiting toxicities (DLTs) for safety, low, medium, and high dose cohorts of single and repeatedly administered AUP1602-C
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]• Incidence of AEs
- Incidence of Wound Closure [ Time Frame: 6 months ]
- Percentage (%) of patients with a target ulcer achieving complete wound closure
- Percentage (%) of wound size reduction (wound area measurements in cm^2)
- Incidence of Wound Closure [ Time Frame: 6 months ]
- Percentage (%) of wound area (cm^2) reduction
- Percentage (%) of wound depth (mm) reduction
- Percentage (%) of wound volume (mm^3) reduction
Measurements will be aggregated: Wound are and depth will be used to calculate wound volume.
- Incidence of ulcer recurrence [ Time Frame: 6 months ]Percentage (%) of patients with ulcer recurrence
- Incidence of Wound Infections [ Time Frame: 6 months ]Proportion of patients with local wound infections related to the target ulcer
- Incidence of surgical procedures [ Time Frame: 6 months ]
- Number of patients with local surgical procedures
- Incidence of amputations (minor or major) related to the target ulcer
- Changes in Quality of Life according to EQ-5D-5L [ Time Frame: 6 months ]Change from baseline in health-related quality is assessed according to EuroQoL-5 Dimensions (EQ-5D-5L) patient quesionnaire. Five single-item dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. Result of the questionnaire is scored from 0 (worst health imaginable) to 100 (best health imaginable).
- Changes in Quality of Life according to DLQI [ Time Frame: 6 months ]Change from baseline in health-related quality is assessed according to Dermatology Life Quality Index (DLQI). It consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score will be calculated as the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
- Changes in pain assessment according to VAS [ Time Frame: 6 months ]Change from baseline in patient's pain intensity according to a numerical Visual Analog Scale (VAS) ranging from 0 = no pain to 10= worst imaginable pain.
- Incidence of Adverse Events [ Time Frame: 6 months ]
- Incidence of abnormal vital signs
- Incidence of abnormal ECG data
- Incidence of abnormal echocardiogram data
- Incidence of abnormal ophthalmoscopy data
- Incidence of abnormal physical examination findings
- Incidence of abnormal laboratory data
- Incidence of bacteria distribution [ Time Frame: 6 months ]Assessment of biodistribution and shedding (yes / no)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04281992
|Contact: Haritha Samaranayake, MDemail@example.com|