Clinical trial NCT01474473: Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot
Official title: A Pilot Placebo-Controlled, Randomized and Double Blind Monocenter Study Evaluating CACIPLIQ20 Efficacy On Neuropathic Perforating Foot Ulcer Healing In Diabetic Patients Wearing An Irremovable Windowed Resin Cast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Ulcer
Diabetes Mellitus
Diabetic Neuropathy
Keywords: CACIPLIQ20
Matrix Therapy
Diabetic foot
Lead sponsor: Organ, Tissue, Regeneration, Repair and Replacement
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 extracellular matrix, by binding to structural proteins, and 2) in the cell communication by protecting growth factors. At the site of a lesion, glycosaminoglycans are degraded, thereby the extracellular matrix is disorganized and the tissue is destroyed. By replacing damaged glycosaminoglycans, CACIPLIQ20 provides a protective function and restores the matrix architecture and the cell communication, a process known as Matrix Therapy.

As for now, three non-controlled pilot studies have been carried out on small populations. They have shown a substantial enhancement of chronic wounds state after treatment with CACIPLIQ20. Therefore, the purpose of this new controlled study is to determine whether CACIPLIQ20 can shorten diabetic neuropathic plantar ulcers healing when the off-loading is mandatory.

The study's main hypothesis is that CACIPLIQ20 application on a non-healing diabetic plantar ulcer in an off-loading mandatory context would reinitiate the natural process of tissue regeneration and lead to total wound closure faster than following standard wound care.

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 amputation is performed every 30 seconds in the world. Textbook-case of perforating foot ulcer (Malum Perforans Pedis) is caused by a mechanical impairment : only a thoroughly observed discharge may lead to good wound care and, ultimately, healing. Thus, this study proposes the utilization of an nonremovable windowed Fiberglass Cast Boot, a technique which has led to healing in 6 to 8 weeks for 95% of neuropathic foot ulcers treated that way.

As 80% of amputations are caused by non-healing ulcers, it appears obvious that enhancing foot wounds healing could reduce amputation rate and in that way fairly improve diabetic patients' quality of life.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Kinetics of Evolution of wound size within 60 days
timeFrame: 60 days
Secondary outcomes:
measure: Evolution of remaining lesion rate
timeFrame: 8, 15, 30, 45 and 60 days
measure: Healing rate
timeFrame: 8, 15, 30, 45 and 60 days
measure: Number of declared full wound healings
timeFrame: 8, 15, 30, 45 and 60 days
measure: Number of wounds leading to amputation
timeFrame: 8, 15, 30, 45 and 60 days
measure: Pain experienced during time
timeFrame: Recruitment, 8, 15, 30, 45 and 60 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
Study officials:
affiliation: Pitié-Salpêtrière Hospital, Paris
name: Georges Ha Van, MD
role: PRINCIPAL_INVESTIGATOR
References: