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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier:
NCT01474473
First received: October 31, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Foot Ulcer
Diabetes Mellitus
Diabetic Neuropathy
Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot
Device: Placebo and Nonremovable, Windowed, Fiberglass Cast Boot

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

Resource links provided by NLM:


Further study details as provided by Organ, Tissue, Regeneration, Repair and Replacement:

Primary Outcome Measures:
  • Kinetics of Evolution of wound size within 60 days [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of remaining lesion rate [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]
    Remaining lesion rate, defined as the ratio of lesion surface at the specified time to lesion surface before treatment, during time

  • Healing rate [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]
    Healing rate, defined as the difference between two lesion rates at different times

  • Number of declared full wound healings [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]
    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

  • Number of wounds leading to amputation [ Time Frame: 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]
    Number of wounds causing new amputations during time, as recorded after surgical measures sustained by patients

  • Pain experienced during time [ Time Frame: Recruitment, 8, 15, 30, 45 and 60 days ] [ Designated as safety issue: No ]
    Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: March 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Comparator: 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.
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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474473

Locations
France
Pitié-Salpêtrière Hospital
Paris, France, 75013
Sponsors and Collaborators
Organ, Tissue, Regeneration, Repair and Replacement
Investigators
Principal Investigator: Georges Ha Van, MD Pitié-Salpêtrière Hospital, Paris
  More Information

No publications provided

Responsible Party: Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier: NCT01474473     History of Changes
Other Study ID Numbers: CT11Q09UPND
Study First Received: October 31, 2011
Last Updated: April 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Organ, Tissue, Regeneration, Repair and Replacement:
CACIPLIQ20
Matrix Therapy
Diabetic foot

Additional relevant MeSH terms:
Diabetes Mellitus
Ulcer
Foot Ulcer
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on September 18, 2014