Status:
COMPLETED
Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot
Lead Sponsor:
Organ, Tissue, Regeneration, Repair and Replacement
Conditions:
Foot Ulcer
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
CACIPLIQ20 is a nanopolymer engineered to mimic glycosaminoglycans such as heparan sulfates. Glycosaminoglycans are implied 1) in the stabilization of the micro-environment of cells, known as extracel...
Detailed Description
This study specifically targets diabetic patients presenting neuropathic plantar ulcers. Diabetic patients have a 25% risk to develop foot ulcers during their life, and one diabetes-induced amputatio...
Eligibility Criteria
Inclusion
- Perforating non-ischemic plantar ulcer with neuropathy in a diabetic patient
- Wound not healing for no less than 6 weeks, based on recruitment examination
- Wound surface spanning from 1 cm² to 10 cm²
- Foot off-loaded by a non-removable windowed, fiberglass cast boot
- Age of inclusion ≥ 18 years
- A contraceptive method must be used for women of childbearing age
- Realization of a preliminary physical examination
Exclusion
- Wound not located on the foot, or ischemic, with edema, erythema, maceration or eczema
- Infection clinically approved (Fever, pus...)
- Osteitis
- Known hypersensitivity to heparin
- Treatment with Negative Pressure Wound Therapy within 30 days prior to enrollment
- Treatment ongoing or within 30 days prior to enrollment with growth factors or other biotechnology products
- Treatment ongoing or within 12 months prior to enrollment with hyperbaric oxygen therapy
- Patient with liver or kidney failure
- Patient with a known heavy condition that could require corticosteroid, anti-inflammatory or immunosuppressant treatments
- Patient already enrolled in a therapeutic clinical study focusing on an experimental molecule
- Pregnant or breastfeeding woman, or likely to be
- Non-affiliation to the French social security system
- Patient unable to attend to scheduled medical monitoring due to geographical, social or mental reasons
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01474473
Start Date
August 1 2011
End Date
March 1 2014
Last Update
April 9 2014
Active Locations (1)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013