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

Diabetes Mellitus Clinical Trial

— DIAPLIQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474473
• Other study ID #: CT11Q09UPND
• Status: Completed
• Phase: N/A
• First received: October 31, 2011
• Last updated: April 8, 2014
• Start date: August 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Organ, Tissue, Regeneration, Repair and Replacement
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Diabetic Neuropathy
• Foot Ulcer
• Ulcer

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
France	Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Organ, Tissue, Regeneration, Repair and Replacement

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of Evolution of wound size within 60 days		60 days	No
Secondary	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	No
Secondary	Healing rate	Healing rate, defined as the difference between two lesion rates at different times	8, 15, 30, 45 and 60 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No