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Completed

NCT Number: NCT01474473

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pitié-Salpêtrière Hospital

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Kinetics of Evolution of wound size within 60 days

    Time frame: 60 days

Secondary outcomes

  1. Evolution of remaining lesion rate

    Time frame: 8, 15, 30, 45 and 60 days

    Remaining lesion rate, defined as the ratio of lesion surface at the specified time to lesion surface before treatment, during time

  2. Healing rate

    Time frame: 8, 15, 30, 45 and 60 days

    Healing rate, defined as the difference between two lesion rates at different times

  3. Number of declared full wound healings

    Time frame: 8, 15, 30, 45 and 60 days

    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

  4. Number of wounds leading to amputation

    Time frame: 8, 15, 30, 45 and 60 days

    Number of wounds causing new amputations during time, as recorded after surgical measures sustained by patients

  5. Pain experienced during time

    Time frame: Recruitment, 8, 15, 30, 45 and 60 days

    Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used

Sponsors and collaborators

Lead sponsor

Organ, Tissue, Regeneration, Repair and Replacement

Industry

Registry information

Official study 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

Acronym: DIAPLIQ

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2011
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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