Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy

Intervention / Treatment
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* Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot
* Device: Placebo and Nonremovable, Windowed, Fiberglass Cast Boot


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CACIPLIQ20 and Cast Boot<br>This arm receives treatment by CACIPLIQ20 application every 3 to 4 days and the wounded leg is held with a nonremovable, windowed, fiberglass Cast Boot. | Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot<br>* The Nonremovable, Windowed, Fiberglass Cast Boot is implemented before the beginning of CACIPLIQ20 treatment and is maintained during the treatment. CACIPLIQ20 is applied on the wound for 10 minutes every 3 to 4 days<br>|
| Placebo Comparator: Placebo and Cast Boot<br>This arm receives a placebo (saline solution) every 3 to 4 days and the wounded leg is held with a nonremovable, windowed, fiberglass Cast Boot. | Device: Placebo and Nonremovable, Windowed, Fiberglass Cast Boot<br>* The Nonremovable, Windowed, Fiberglass Cast Boot is implemented before the beginning of placebo treatment and is maintained during the treatment. Placebo is applied on the wound for 10 minutes every 3 to 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinetics of Evolution of wound size within 60 days |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of remaining lesion rate | Remaining lesion rate, defined as the ratio of lesion surface at the specified time to lesion surface before treatment, during time | 8, 15, 30, 45 and 60 days | 
| Healing rate | Healing rate, defined as the difference between two lesion rates at different times | 8, 15, 30, 45 and 60 days | 
| Number of declared full wound healings | Number of declared full wound healings during time, defined as non-oozing wound closure without any reopening after no less than 15 days, ascertained by the principal investigator and another member of his team | 8, 15, 30, 45 and 60 days | 
| Number of wounds leading to amputation | Number of wounds causing new amputations during time, as recorded after surgical measures sustained by patients | 8, 15, 30, 45 and 60 days | 
| Pain experienced during time | Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used | Recruitment, 8, 15, 30, 45 and 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CACIPLIQ20, Matrix Therapy, Diabetic foot