Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot (DIAPLIQ)
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.
|Foot Ulcer Diabetes Mellitus Diabetic Neuropathy||Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot Device: Placebo and Nonremovable, Windowed, Fiberglass Cast Boot|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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|
- Kinetics of Evolution of wound size within 60 days [ Time Frame: 60 days ]
- 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
- Healing rate [ Time Frame: 8, 15, 30, 45 and 60 days ]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 ]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 ]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 ]Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used
|Study Start Date:||August 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474473
|Paris, France, 75013|
|Principal Investigator:||Georges Ha Van, MD||Pitié-Salpêtrière Hospital, Paris|