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

Primary Purpose

Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot

Placebo and Nonremovable, Windowed, Fiberglass Cast Boot

About this trial

This is an interventional treatment trial for Foot Ulcer focused on measuring CACIPLIQ20, Matrix Therapy, Diabetic foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Pitié-Salpêtrière Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CACIPLIQ20 and Cast Boot

Placebo and Cast Boot

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Kinetics of Evolution of wound size within 60 days

Secondary Outcome Measures

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

Healing rate

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

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

Number of wounds leading to amputation

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

Pain experienced during time

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

Full Information

NCT ID

NCT01474473

First Posted

October 31, 2011

Last Updated

April 8, 2014

Sponsor

Organ, Tissue, Regeneration, Repair and Replacement

1. Study Identification

Unique Protocol Identification Number

NCT01474473

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organ, Tissue, Regeneration, Repair and Replacement

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy

Keywords

CACIPLIQ20, Matrix Therapy, Diabetic foot

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CACIPLIQ20 and Cast Boot

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo and Cast Boot

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot

Intervention Description

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

Intervention Name(s)

Placebo and Nonremovable, Windowed, Fiberglass Cast Boot

Intervention Description

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 Outcome Measure Information:

Title

Kinetics of Evolution of wound size within 60 days

Time Frame

60 days

Secondary Outcome Measure Information:

Title

Evolution of remaining lesion rate

Description

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

Time Frame

8, 15, 30, 45 and 60 days

Title

Healing rate

Description

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

Time Frame

8, 15, 30, 45 and 60 days

Title

Number of declared full wound healings

Description

Time Frame

8, 15, 30, 45 and 60 days

Title

Number of wounds leading to amputation

Description

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

Time Frame

8, 15, 30, 45 and 60 days

Title

Pain experienced during time

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georges Ha Van, MD

Organizational Affiliation

Pitié-Salpêtrière Hospital, Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pitié-Salpêtrière Hospital

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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