Safety Study to Examine the Systemic Exposure of Granexin® Gel After Topical Application to Diabetic Foot Ulcers
NCT02652754 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2018-08-01
Summary
The purpose of this study is to determine the systemic exposure of Granexin® gel after topical application to human subjects' diabetic foot ulcers.
Conditions
- Diabetic Foot Ulcers
Interventions
- DRUG
-
Granexin® gel
Granexin® gel will be dispensed directly from a 5 gram laminate tube and will be spread and smoothed directly over the wound surface in full contact with the wound bed to obtain an even, uniform layer on Day 0 (baseline), Day 3, and Day 7.
Sponsors & Collaborators
-
Medical University of South Carolina
collaborator OTHER -
Spartanburg Regional Healthcare System
collaborator OTHER -
Xequel Bio, Inc.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2017-12-31
- Completion
- 2018-05-31
Countries
- United States
Study Locations
More Related Trials
-
Macrophage Stimulating Factor in the Treatment of Diabetic Wounds
NCT06608303 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of rhEGF in Diabetic Foot Ulcer Patients With Uncontrolled Diabetic Mellitus
NCT01629199 ·Status: COMPLETED ·Phase: PHASE3
-
Phase III Study to Evaluate Efficacy and Safety of DSC127 in Diabetic Foot Ulcers
NCT01830348 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of GM-XANTHO in Pressure Ulcer Patients
NCT05199077 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Clinical Trial Evaluating the Safety and Efficacy of the Use of Chitosan Gel in Patients With Chronic Wounds
NCT04178525 ·Status: TERMINATED ·Phase: NA
-
A Study Evaluating Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) for Induction of Healing of Chronic, Diabetic Foot Ulcers
NCT00069446 ·Status: COMPLETED ·Phase: PHASE1
-
Open-Label Study in Diabetic Foot Ulcers (DFU), to Evaluate Safety of 0.03% DSC127 Topical Gel in Chronic Use
NCT01840085 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
NCT01490879 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Preliminary Efficacy Study of Nicotine Gel to Treat Diabetic Foot Ulcers
NCT00316537 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
The Risk of Cancer in Users of Regranex (Becaplermin) and Matched Comparators (Nonusers of Regranex [Becaplermin])
NCT00518102 ·Status: COMPLETED
-
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds
NCT05570877 ·Status: COMPLETED ·Phase: NA
-
Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers
NCT02427802 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Evaluation of the Intralesional Recombinant Human Epidermal Growth Factor (rhEGF) in Subjects With Diabetic Foot Ulcer.
NCT02554851 ·Status: UNKNOWN ·Phase: PHASE3
-
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
NCT00662831 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
NCT02036528 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
NCT00764361 ·Status: COMPLETED ·Phase: PHASE2
-
CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
NCT07206862 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Phase 2a Proof of Concept Open-Label, Randomized, Controlled Study to Evaluate the Safety and Efficacy of MDI-1228-mesylate Gel Compared With Standard of Care Alone in Patients With Diabetic Foot Ulcers
NCT06852976 ·Status: RECRUITING ·Phase: PHASE2
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
NCT01831804 ·Status: COMPLETED ·Phase: PHASE1
-
Effect of rhGM-CSF on the Healing of Venous Leg Ulcers
NCT04823962 ·Status: UNKNOWN ·Phase: PHASE2
-
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
NCT01982565 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
NCT05586542 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
NCT00796744 ·Status: COMPLETED ·Phase: PHASE2
-
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
NCT00389636 ·Status: UNKNOWN ·Phase: NA
-
Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone
NCT06455475 ·Status: RECRUITING ·Phase: NA