Foot UlcerDIAPLIQNCT01474473
Efficacy Of CACIPLIQ20 On Diabetic Ulcers In Patients Wearing An Nonremovable, Windowed, Fiberglass Cast Boot
A study testing CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot in people with Foot Ulcer and Diabetes Mellitus, run by Organ, Tissue, Regeneration, Repair and Replacement at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy
- What is being tested?
- CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy
- Being tested
- CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot, Placebo and Nonremovable, Windowed, Fiberglass Cast Boot
- Keywords
- CACIPLIQ20, Matrix Therapy, Diabetic foot
- Medical subject headings
- Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast BootDevice
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 BootDevice
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
| Study group | Role | What they receive |
|---|---|---|
| CACIPLIQ20 and Cast Boot | Experimental | 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. Receives: Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot |
| Placebo and Cast Boot | Placebo comparator | 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. Receives: Device: Placebo and Nonremovable, Windowed, Fiberglass Cast Boot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinetics of Evolution of wound size within 60 days
Measured: 60 days
Secondary outcomes (5)
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
Measured: 8, 15, 30, 45 and 60 days
Healing rate
Healing rate, defined as the difference between two lesion rates at different times
Measured: 8, 15, 30, 45 and 60 days
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
Measured: 8, 15, 30, 45 and 60 days
Number of wounds leading to amputation
Number of wounds causing new amputations during time, as recorded after surgical measures sustained by patients
Measured: 8, 15, 30, 45 and 60 days
Pain experienced during time
Pain experienced by patients, assessed with Numerical Rating Pain Scale (0 to 10) and amount of painkillers used
Measured: Recruitment, 8, 15, 30, 45 and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georges Ha Van, MD, Principal investigator, Pitié-Salpêtrière Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474473
- Sponsor's protocol ID
- CT11Q09UPND
- Acronym
- DIAPLIQ
- Status last verified
- Apr 2014
- First submitted
- 31 Oct 2011
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01474473
- Acronym / sponsor ID
- DIAPLIQ / CT11Q09UPND
- Conditions
- Foot Ulcer, Diabetes Mellitus, Diabetic Neuropathy
- Keywords
- CACIPLIQ20, Matrix Therapy, Diabetic foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Organ, Tissue, Regeneration, Repair and ReplacementIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CACIPLIQ20 and Cast Boot | Experimental | Device: CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast BootThis arm receives treatment by CACIPLIQ20 application every 3 to 4 days and the wounded leg is held with a nonremovable, windowed, fiberglass Cast Boot. |
| Placebo and Cast Boot | Placebo comparator | Device: Placebo and Nonremovable, Windowed, Fiberglass Cast BootThis arm receives a placebo (saline solution) every 3 to 4 days and the wounded leg is held with a nonremovable, windowed, fiberglass Cast Boot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast BootThe 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 | Device | CACIPLIQ20 and Cast Boot |
| Placebo and Nonremovable, Windowed, Fiberglass Cast BootThe 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 | Device | Placebo and Cast Boot |
Primary outcome
Kinetics of Evolution of wound size within 60 days
Time frame: 60 days
5 secondary outcomes
Evolution of remaining lesion rate
Time frame: 8, 15, 30, 45 and 60 days
Healing rate
Time frame: 8, 15, 30, 45 and 60 days
Number of declared full wound healings
Time frame: 8, 15, 30, 45 and 60 days
Number of wounds leading to amputation
Time frame: 8, 15, 30, 45 and 60 days
Pain experienced during time
Time frame: Recruitment, 8, 15, 30, 45 and 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges Ha Van, MD principal investigator
Pitié-Salpêtrière Hospital, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot in people with Foot Ulcer and Diabetes Mellitus, run by Organ, Tissue, Regeneration, Repair and Replacement at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinetics of Evolution of wound size within 60 days (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.