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

NCT ID: NCT01474473

Last Updated: 2014-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-03-31

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.

Conditions

Foot Ulcer; Diabetes Mellitus; Diabetic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CACIPLIQ20 and Cast Boot

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.

Group Type: EXPERIMENTAL

CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot

Intervention Type: DEVICE

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

Placebo and Cast Boot

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.

Group Type: PLACEBO_COMPARATOR

Placebo and Nonremovable, Windowed, Fiberglass Cast Boot

Intervention Type: DEVICE

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

Interventions

CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot

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

Intervention Type: DEVICE

Placebo and Nonremovable, Windowed, Fiberglass Cast Boot

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organ, Tissue, Regeneration, Repair and Replacement

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georges Ha Van, MD

Role: PRINCIPAL_INVESTIGATOR

Pitié-Salpêtrière Hospital, Paris

Locations

Pitié-Salpêtrière Hospital

Paris, , France

Countries

France

Other Identifiers

CT11Q09UPND

Identifier Type: -

Identifier Source: org_study_id