Skin UlcerNCT02309684
Bio-ConneKt Wound Dressing for Treatment of Chronic Leg Wounds: A Pilot Study
An observational study of Skin Ulcer, run by MLM Biologics Inc.,.
Trial summary
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Observational
- 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
Study population: A total of 20 patients with DFU (n=10) and VLU (n=10) will be considered in this study if they sign the informed consent, and meet all inclusion criteria and none of the exclusion criteria.
Who may be able to join
- A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound
- The ulcer has been diagnosed/present for greater than 4 weeks duration.
- Three or fewer ulcers separated by > 3.0 cm distance
- Post-debridement, the ulcer size must be > 5 sq cm
- Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:
- transcutaneous partial pressure oxygen (TcPO2) > 30 mmHg at the ankle
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- toe pressure of >40mm Hg or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
- At least 18 years old
- Able and willing to read and sign a voluntary written informed consent
- Able and willing to attend scheduled follow-up visits and study related exams
Who cannot join
- Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator
- Ulcer with exposed tendon or bone
- Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
- Known severe anemia
- Known serum albumin < 2.5
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- Renal failure requiring dialysis
- Rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
- Severe liver disease as defined by the treating physician or patient's primary care physician
- Malignancy at or near the ulcer site
- Any condition judged by the investigator that would cause the study to be detrimental to the patient
- Presence of a hematology, clinical, chemistry or other test obtained within 7 days of screening that is outside the normal range for the laboratory and is determined to be clinically significant by the investigator
- Received another investigational device or drug within 30 days of Day 0.
- Radiation therapy, chemotherapy or immunosuppressive therapy within 30 days of enrollment
- Received another allograft, autograft or xenograft within 30 days of the Day 0/
- Known allergy to equine derived tissue
- Alcohol or drug abuse, defined as current medical treatment for substance abuse
- Pregnant or nursing women
Trial locations and contacts
No sites are listed yet.
Elmer Croushore, MD contact
About this study
Official title: The Clinical & Economic Evaluation of Bio-ConneKt® Wound Dressing in Treating Chronic Foot Ulcers (Diabetic and/or Venous Ulcers).
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.
- Conditions
- Skin Ulcer
- Keywords
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
- Medical subject headings
- Skin Ulcer, Diabetic Foot, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Study population are subjects at least 18 years old and of any ethnic background with a full thickness diabetic foot ulcer or venous leg ulcer, where the ulcer has been diagnosed/present for greater than 4 weeks duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound closure
Time to complete wound closure and percent wounds healed at 12 weeks
Measured: Weekly assessment up to 12 weeks
Secondary outcomes (1)
Rate of Wound Closure
Mean and median wound size changes at 4, 6, 12 \& 24 weeks, along with ulcer recurrence and/or device related adverse events.
Measured: 4, 6, 12 & 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MLM Biologics Inc.,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elmer Croushore, MD, Principal investigator, NFRMC Wound Therapy Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309684
- Sponsor's protocol ID
- MLM1301
- Status last verified
- Dec 2014
- First submitted
- 3 Dec 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical & Economic Evaluation of Bio-ConneKt® Wound Dressing in Treating Chronic Foot Ulcers (Diabetic and/or Venous Ulcers).
- ClinicalTrials.gov ID
- NCT02309684
- Acronym / sponsor ID
- MLM1301
- Conditions
- Skin Ulcer
- Keywords
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcer (VLU)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MLM Biologics Inc.,Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 5 Dec 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.
The purpose of this study is to assess the performance of the bio-ConneKt™ wound dressing and compare its performance with the standard of care at NFRMC Wound Therapy Services, for the treatment of chronic foot/leg ulcers (DFU/VLU) in a prospective single center open one-arm clinical study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | –Study population are subjects at least 18 years old and of any ethnic background with a full thickness diabetic foot ulcer or venous leg ulcer, where the ulcer has been diagnosed/present for greater than 4 weeks duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 20 patients with DFU (n=10) and VLU (n=10) will be considered in this study if they sign the informed consent, and meet all inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (10 listed)
- A full thickness diabetic foot ulcer with a viable wound bed free of necrotic material (grade 1 on Wagner scale) or a venous leg ulcer confirmed with duplex ultrasound
- The ulcer has been diagnosed/present for greater than 4 weeks duration.
- Three or fewer ulcers separated by > 3.0 cm distance
- Post-debridement, the ulcer size must be > 5 sq cm
- Ankle / brachial index is between 0.7 to 1.2 and or one of the following must be present:
Key exclusion criteria (18 listed)
- Greater than 30% reduction in wound size (DFU) or 20% reduction in VLU during first week of observation by the investigator
- Ulcer with exposed tendon or bone
- Gross clinical infection at the study ulcer site including cellulitis and osteomyelitis
- Ulcer of a non-diabetic/non-venous pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis related ulcers)
- Known severe anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to complete wound closure
Time frame: Weekly assessment up to 12 weeks
Time to complete wound closure and percent wounds healed at 12 weeks
1 secondary outcome
Rate of Wound Closure
Time frame: 4, 6, 12 & 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 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.
Elmer Croushore, MD contact
Elmer Croushore, MD principal investigator
NFRMC Wound Therapy Services
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Ulcer, run by MLM Biologics Inc.,.
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 18 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: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elmer Croushore, MD (352-538-3180), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete wound closure (time frame: Weekly assessment up to 12 weeks). 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 5 Dec 2014.