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

NCT01474473 | Completed

• 1 other identifier: CT11Q09UPND
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer; Diabetes Mellitus; Diabetic Neuropathy

Keywords

CACIPLIQ20; Matrix Therapy; Diabetic foot

Outcome Measures

Primary Outcomes (1)

• Kinetics of Evolution of wound size within 60 days

  60 days

Secondary Outcomes (5)

• Evolution of remaining lesion rate

  8, 15, 30, 45 and 60 days

• Healing rate

  8, 15, 30, 45 and 60 days

• Number of declared full wound healings

  8, 15, 30, 45 and 60 days

• Number of wounds leading to amputation

  8, 15, 30, 45 and 60 days

• Pain experienced during time

  Recruitment, 8, 15, 30, 45 and 60 days

Study Arms (2)

CACIPLIQ20 and Cast Boot

EXPERIMENTAL

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

Placebo and Cast Boot

PLACEBO COMPARATOR

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

Interventions

CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot 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

CACIPLIQ20 and Cast Boot

Placebo and Nonremovable, Windowed, Fiberglass Cast Boot 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

Placebo and Cast Boot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• A contraceptive method must be used for women of childbearing age
• Realization of a preliminary physical examination

You may not qualify if:

• 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

Sponsors & Collaborators

• Organ, Tissue, Regeneration, Repair and Replacement: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Foot Ulcer; Diabetes Mellitus; Diabetic Neuropathies; Diabetic Foot

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Georges Ha Van, MD

  Pitié-Salpêtrière Hospital, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 18, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

FR (1)