Diabetic Foot UlcersNCT01353495
Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
A study testing APM Graft (BIOTAPE XMTM) and Wound Debridement in people with Diabetic Foot Ulcers, run by Stryker Trauma and Extremities at 2 sites in United States.
Trial summary
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- APM Graft (BIOTAPE XMTM) and Wound Debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female age 18 or older
- Informed consent must be obtained
- Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Patient's ulcer must exhibit no clinical signs of infection.
- Patient is of legal consenting age.
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- Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg, OR
- ABIs with results of ≥0.7 and ≤1.2, OR
- Doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg
Who cannot join
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,
- Patients whose serum creatinine levels are 3.0mg/dl or greater.
- Patients with a known history of poor compliance with medical treatments.
- Patients who have been previously randomized into this study, or are presently participating in another clinical trial
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- Patients who are currently receiving radiation therapy or chemotherapy.
- Patients with known or suspected local skin malignancy to the index diabetic ulcer.
- Patients on anticoagulant medication will as in any surgical procedure, be monitored According to the protocols employed at the enrolling center.
- Patients diagnosed with autoimmune connective tissues diseases.
- Nonrevascularable surgical sites
- Active infection at site
- Sensitivity to the following antibiotics: Gentamicin, Cefoxilin, Linocmycin, Polymyxin B, Vancomycin
- Any pathology that would limit the blood supply and compromise healing;
- Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Advanced Foot Care and Clinincal Research Center
Fresno, California, 93722
Professional Education & Research Institute
Roanoke, Virginia, 24016
About this study
Official title: A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
Read the detailed description
The primary objective of this study is time -to - healing with wound size determination at 12 weeks.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- APM Graft (BIOTAPE XMTM), Wound Debridement
- Keywords
- Diabetic Foot Ulcers
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APM Graft (BIOTAPE XMTM)Device
Also called BIOTAPE XMTM
Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
Wound DebridementOther
Wounds debrided in both arms of study
| Study group | Role | What they receive |
|---|---|---|
| APM Graft (BIOTAPE XMTM | Experimental | graft applied to wound q 3 weeks for 12 weeks Receives: Device: APM Graft (BIOTAPE XMTM); Other: Wound Debridement |
| standard wound care | Active comparator | Wound debridement and gels and foams applied to wound weekly for 12 weeks. Receives: Other: Wound Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- More trials run by Stryker Trauma and ExtremitiesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Trauma and Extremities
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jagpreet Mukker, DPM, Principal investigator, Advanced Foot Care and Clinincal Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353495
- Sponsor's protocol ID
- 009-BIO-001
- Status last verified
- May 2021
- First submitted
- 11 May 2011
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparative Parallel Study of Acellular Porcine Dermal Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01353495
- Acronym / sponsor ID
- 009-BIO-001
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Stryker Trauma and ExtremitiesIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 13 May 2011 (estimated)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Have indolent diabetic ulcers completely healed by the Acellular Porcine Dermal Matrix (APM) in 12 weeks.
Detailed description
The primary objective of this study is time -to - healing with wound size determination at 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APM Graft (BIOTAPE XMTM | Experimental | Device: APM Graft (BIOTAPE XMTM), Other: Wound Debridementgraft applied to wound q 3 weeks for 12 weeks |
| standard wound care | Active comparator | Other: Wound DebridementWound debridement and gels and foams applied to wound weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female age 18 or older
- Informed consent must be obtained
- Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
- Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
- Patient's ulcer must exhibit no clinical signs of infection.
Key exclusion criteria (15 listed)
- Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
- Patients whose index diabetic foot ulcers are greater than 25cm2.
- Patients considered not in reasonable metabolic control, confirmed by an HgA1c greater than 12% within previous 90 days,
- Patients whose serum creatinine levels are 3.0mg/dl or greater.
- Patients with a known history of poor compliance with medical treatments.
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 |
|---|---|---|
| APM Graft (BIOTAPE XMTM)Also: BIOTAPE XMTMPatients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred. | Device | APM Graft (BIOTAPE XMTM |
| Wound DebridementWounds debrided in both arms of study | Other | APM Graft (BIOTAPE XMTM, standard wound care |
Primary outcome
Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth
Time frame: 12 Weeks
Wound evaluated and granulation described by wound tracing and photographs which will be measures in wound width x length x depth at each week for 12 weeks or until full granulation has occurred in addition to the size of the wound
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcers
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Jagpreet Mukker, DPM principal investigator
Advanced Foot Care and Clinincal Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APM Graft (BIOTAPE XMTM) and Wound Debridement in people with Diabetic Foot Ulcers, run by Stryker Trauma and Extremities at 2 sites 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 11 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 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Size of Index Wound Based on Calculations Wound Width x Length x Depth 2. Size of Index Wound Based on Calculations Wound Width x Length x Depth (time frame: 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 14 Jun 2021.