Foot UlcerPhase 1EZCast-DFUNCT02131961
EZCast-DFU Study With Portal for Application of Topical Medications
A Phase 1 study testing Collagenase ointment and Modified Contact Cast System in people with Foot Ulcer and Diabetic Foot, run by University of Miami at 1 site in United States.
Trial summary
This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Foot Ulcer, Diabetic Foot
- What is being tested?
- Collagenase ointment and Modified Contact Cast System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2
- Patients must sign an informed consent
- Diabetic medications must be stable for 4 weeks prior to randomization.
- Patients with a plantar ulcer
- Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2
- Patients must agree to comply with at least daily dressing changes and off-loading according to protocol requirements;
Show all 10Show fewer
- Ulcer at least 6 weeks but not more than 12 months old
- Diabetic patients who use a medication to lower blood glucose levels who, in the opinion of the investigator, are considered "controlled" diabetics
- Adequate perfusion of the foot with the ulcer
- No prior use of Santyl on the target ulcer or treatment within one month with other bioactive therapies
Who cannot join
- Patients with more than two ulcers on the same foot
- Patients with ulcer requiring off-loading that cannot be effectively off-loaded
- Patients with ulcer above the plantar foot;
- Patient non-compliance with protocol-required off-loading and dressing change
- Patients with infected ulcers
- Patients with severe edema (defined as inability to fit leg into off-loading device);
Show all 15Show fewer
- Patients with a gangrenous or ischemic toe that may need to be amputated in the opinion of the investigator;
- Patients with Buerger's disease, vasculitis or connective tissue disease;
- Ankle brachial index >1.2 (ABI >1.2 must be confirmed by another method such as Transcutaneous partial pressure oxygen (TcPO2) > 40 mm Hg at the ankle or Toe pressure of > 40mm Hg or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic) or Skin Perfusion Pressure (SPP) > 40 mm Hg);
- Patients with claudication
- Body mass index (BMI) > 40 kg/m2
- There is active Charcot's joint by clinical or radiographic criteria.
- Unable or unwilling to provide informed consent.
- Known HIV infection and/or AIDS based on participant self-report.
- Patients with contraindication to contact casting (ie. peripheral vascular disease, Infection)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, University of Miami Hospital & Clinics
Miami, Florida, 33136
About this study
Official title: A Study to Evaluate the Feasibility of Using a Modified Cast Walker With a Portal for Application of Topical Medications in Diabetic Foot Ulcers
This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.
Read the detailed description
The accepted care of a diabetic foot ulcer includes cleaning of the wound of the dead and dying tissue around the wound, daily wound care, good nutrition, and adequate relief of pressure. Pressure reduction, commonly known as "off-loading," is most often achieved by having the patient wear an "off-loading boot". However, using a cast similar to the cast used to treat broken bones will result in less activity and better wound healing. The cast is considered the best method for off-loading the foot but is not used as often as other methods because the cast covers the foot ulcer and it does not allow you to perform daily cleaning and examination.
This study will apply a Total Contact Cast (TCC)System and leave an opening where the ulcer can be treated on a daily basis by the investigators. Patients will be asked to apply an ointment called Santyl ® to their ulcer on a daily basis. Santyl ® ointment is an FDA approved drug that is routinely used on foot ulcers. The Santyl ® ointment cleans wounds to promote a better environment for wounds to heal. It helps remove nonliving tissue without harming the new healing tissue.
Trial will last 14 days and it will consist of 4 visits. In the first visits, patients' wounds will be cleaned from dead and dying tissue (debridement) and the first modified contact cast will be applied. Patients will be provided Santyl to apply daily with reapplication of foam dressing. Patients will return at day 3, and then weekly for 2 weeks for standard evaluation and debridement and wound measurements and at day 3, and week 1 visit for reapplication of the modified contact cast.
- Conditions
- Foot Ulcer, Diabetic Foot
- Being tested
- Collagenase ointment, Modified Contact Cast System
- Keywords
- diabetic foot, foot ulcer, foot wound, plantar ulcer, plantar wound, contact cast, collagenase
- Medical subject headings
- Foot Ulcer, Diabetic Foot, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase ointmentDrug
Also called Santyl
250 collagenase units/g
Modified Contact Cast SystemDevice
Also called Modified TCC-EZ(R) Total Contact Cast System
1 Unit
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Collagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7. Receives: Drug: Collagenase ointment; Device: Modified Contact Cast System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of contact cast systems intact by day 14
Proportion of contact cast systems in whom the investigator assesses as intact (not damaged, or broken by the creation of the window).
Intact: Contact cast systems where the window creation did not create unintended fissures or these fissures were less than 1cm length and they originate from the window opening.
Damaged: Contact cast systems where window creation creates one or more fissure between 1-3cm of length and these fissures originate from the window opening.
Broken: Contact cast systems where window creation creates one or more fissures of length more than 3 cm, or any fissure that did not originate from the site of the window opening
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionJun 2015
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.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert S. Kirsner, University of Miami
- Investigators
- Robert S Kirsner, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131961
- Sponsor's protocol ID
- 20140171
- Acronym
- EZCast-DFU
- Status last verified
- Jun 2015
- First submitted
- 2 May 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility of Using a Modified Cast Walker With a Portal for Application of Topical Medications in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02131961
- Acronym / sponsor ID
- EZCast-DFU / 20140171
- Conditions
- Foot Ulcer, Diabetic Foot
- Keywords
- diabetic foot, foot ulcer, foot wound, plantar ulcer, plantar wound, contact cast, collagenase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 May 2014 (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.
This study is designed to evaluate the ability to modify a contact cast system so that topical medications can be applied daily to an underlying wound in patients with diabetic plantar ulcers. The modification of the cast will be done by making an opening where the wound is located in the contact cast system. A contact cast system is a device that will reduce the pressure in the area where the wound is located.
Detailed description
The accepted care of a diabetic foot ulcer includes cleaning of the wound of the dead and dying tissue around the wound, daily wound care, good nutrition, and adequate relief of pressure. Pressure reduction, commonly known as "off-loading," is most often achieved by having the patient wear an "off-loading boot". However, using a cast similar to the cast used to treat broken bones will result in less activity and better wound healing. The cast is considered the best method for off-loading the foot but is not used as often as other methods because the cast covers the foot ulcer and it does not allow you to perform daily cleaning and examination.
This study will apply a Total Contact Cast (TCC)System and leave an opening where the ulcer can be treated on a daily basis by the investigators. Patients will be asked to apply an ointment called Santyl ® to their ulcer on a daily basis. Santyl ® ointment is an FDA approved drug that is routinely used on foot ulcers. The Santyl ® ointment cleans wounds to promote a better environment for wounds to heal. It helps remove nonliving tissue without harming the new healing tissue.
Trial will last 14 days and it will consist of 4 visits. In the first visits, patients' wounds will be cleaned from dead and dying tissue (debridement) and the first modified contact cast will be applied. Patients will be provided Santyl to apply daily with reapplication of foam dressing. Patients will return at day 3, and then weekly for 2 weeks for standard evaluation and debridement and wound measurements and at day 3, and week 1 visit for reapplication of the modified contact cast.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: Collagenase ointment, Device: Modified Contact Cast SystemCollagenase ointment topical application, once daily for 14 days, modified Contact Cast System, applied at days 0,3, and 7. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females between 18 and 80 years of age (inclusive) with diabetes type 1 or type 2
- Patients must sign an informed consent
- Diabetic medications must be stable for 4 weeks prior to randomization.
- Patients with a plantar ulcer
- Ulcer with an area between ≥ 1 cm2 and ≤ 10 cm2
Key exclusion criteria (15 listed)
- Patients with more than two ulcers on the same foot
- Patients with ulcer requiring off-loading that cannot be effectively off-loaded
- Patients with ulcer above the plantar foot;
- Patient non-compliance with protocol-required off-loading and dressing change
- Patients with infected ulcers
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 |
|---|---|---|
| Collagenase ointmentAlso: Santyl250 collagenase units/g | Drug | Study arm |
| Modified Contact Cast SystemAlso: Modified TCC-EZ(R) Total Contact Cast System1 Unit | Device | Study arm |
Primary outcome
Proportion of contact cast systems intact by day 14
Time frame: 14 days
Proportion of contact cast systems in whom the investigator assesses as intact (not damaged, or broken by the creation of the window). Intact: Contact cast systems where the window creation did not create unintended fissures or these fissures were less than 1cm length and they originate from the window opening. Damaged: Contact cast systems where window creation creates one or more fissure between 1-3cm of length and these fissures originate from the window opening. Broken: Contact cast systems where window creation creates one or more fissures of length more than 3 cm, or any fissure that did not originate from the site of the window opening
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 10 Jun 2015.
- Wound Research Clinic. University of MiamiLink provided by the sponsor.
Related trials for Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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.
Robert S Kirsner, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Collagenase ointment and Modified Contact Cast System in people with Foot Ulcer and Diabetic Foot, run by University of Miami at 1 site in United States.
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 10 inclusion and 15 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 10 Jun 2015. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of contact cast systems intact by day 14 (time frame: 14 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 10 Jun 2015.