Diabetic Foot UlcersPhase 4NCT01197898
Wound Edge Changes Following Treatment With Santyl
A Phase 4 study testing Collagenase Santyl Ointment in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint at 1 site in United States.
Trial summary
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- What is being tested?
- Collagenase Santyl Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 4
- 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
- To be eligible for the study, subjects must meet the following inclusion criteria:
- Subjects should be presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies. To improve homogeneity in the group studied, subjects with large wounds, complicated wounds, wounds of long duration, or who have failed multiple attempts at healing in which additional known critical variables were addressed (debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply) will be excluded.
- Provide written informed consent.
- Subjects 18 years of age or older, of either sex and of any race, with an existing diagnosis of Type I or Type II Diabetes Mellitus.
- Presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies but not including therapies generally reserved for chronic wounds (i.e., debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply).
- Willing to attend all required study visits, and in the opinion of the Investigator, able to properly follow instructions regarding daily dressing changes (dressing changes may be done by a third party, who must agree to perform these daily).
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- Body Mass Index less than or equal to 40
- A foot wound which meets the following criteria:
- Time since initial skin breakdown 56 - 112 days
- Wagner† Grade 1
- Area between 0.75 and 3.0 cm2, inclusive
- Located on plantar surface of midfoot or forefoot, dorsum of foot, or a post-amputation wound
- Non-infected based on clinical assessment
- Adequate blood supply to the affected foot, defined as meeting a transcutaneous oxygen pressure(TcPO2) measured using standard technique and within 4 cm of the wound of greater than or equal to 35 mmHg.
- Blood chemistry and hematology values as follows, using local lab normal ranges unless otherwise specified:
- Blood Glycated Hemoglobin (HbA1C) 6.5 - 10.5%
- Blood Glucose less than or equal to 180 mg/dL
- Blood Hemoglobin, Hematocrit, Red Blood Cell count within normal limits
- Serum Sodium, Potassium, Calcium, Phosphorus, Carbon Dioxide (CO2) within normal limits
- Serum Albumin greater than or equal to 2.0 g/dL, serum Pre-Albumin greater than or equal to 15 mg/dL
- Alanine Transaminase (ALT), Aspartate Transaminase (AST), Gamma Glutamyl Transpeptidase (GGT) less than or equal to 2.0 x Upper Limit of Normal (ULN)
- Blood Urea Nitrogen, Total Bilirubin, Creatinine less than or equal to 1.5 x ULN
- Wound is able to be off-loaded, if indicated. † Wagner Grade 1 = Superficial ulcer, partial or full-thickness, but not involving underlying fat, fascia, tendon, muscle or bone.
Who cannot join
- Subjects meeting any of the following criteria during the screening period will be excluded from the study:
- Contraindications or hypersensitivity to the use of the study medications or their components
- Therapy with another investigational agent within thirty (30) days of Visit 1.
- Calluses or maceration of periwound area which would interfere with successful biopsy of the wound edge.
- Undermining or tunneling of the target wound.
- Evidence of osteomyelitis on screening roentgenogram of the target foot.
- Coagulation defect or bleeding disorder which, in the opinion of the Investigator, will make the biopsy procedures too risky.
- The Medical Monitor may declare any subject ineligible for a valid medical reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Associated Foot and Ankle Specialists
Phoenix, Arizona, 85015
About this study
Official title: Evaluation of the Edge of Non-Healing Cutaneous Ulcers Following Debridement With Collagenase Santyl Ointment
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Being tested
- Collagenase Santyl Ointment, Placebo Comparator
- Keywords
- Diabetic, Foot, Ulcers, Wounds
- Medical subject headings
- Diabetic Foot, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagenase Santyl OintmentBiological
Topical daily application
Placebo ComparatorOther
Topical daily application
| Study group | Role | What they receive |
|---|---|---|
| Collagenase Santyl | Experimental | Ointment applied once daily Receives: Biological: Collagenase Santyl Ointment |
| Vehicle Base | Placebo comparator | Applied once daily Receives: Other: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.
The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionOct 2012
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, HealthpointArt J Tallis, DPM, Principal investigator, Associated Foot & Ankle Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197898
- Sponsor's protocol ID
- 017-101-09-029
- Status last verified
- Apr 2013
- First submitted
- 26 Aug 2010
- Last updated
- 30 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Edge of Non-Healing Cutaneous Ulcers Following Debridement With Collagenase Santyl Ointment
- ClinicalTrials.gov ID
- NCT01197898
- Acronym / sponsor ID
- 017-101-09-029
- Conditions
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Keywords
- Diabetic, Foot, Ulcers, Wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 30 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate changes in the healing tissue of diabetic foot wounds following 14 days of treatment with Santyl or its vehicle base.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collagenase Santyl | Experimental | Biological: Collagenase Santyl OintmentOintment applied once daily |
| Vehicle Base | Placebo comparator | Other: Placebo ComparatorApplied once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Subjects should be presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies. To improve homogeneity in the group studied, subjects with large wounds, complicated wounds, wounds of long duration, or who have failed multiple attempts at healing in which additional known critical variables were addressed (debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply) will be excluded.
- Provide written informed consent.
- Subjects 18 years of age or older, of either sex and of any race, with an existing diagnosis of Type I or Type II Diabetes Mellitus.
- Presenting for the first time with a complaint of a non-healing wound, or may have failed one or more prior inadequate therapies but not including therapies generally reserved for chronic wounds (i.e., debridement, off loading, wound moisture control, wound infection control, blood glucose control, and/or adequate local blood supply).
- Willing to attend all required study visits, and in the opinion of the Investigator, able to properly follow instructions regarding daily dressing changes (dressing changes may be done by a third party, who must agree to perform these daily).
Key exclusion criteria (8 listed)
- Subjects meeting any of the following criteria during the screening period will be excluded from the study:
- Contraindications or hypersensitivity to the use of the study medications or their components
- Therapy with another investigational agent within thirty (30) days of Visit 1.
- Calluses or maceration of periwound area which would interfere with successful biopsy of the wound edge.
- Undermining or tunneling of the target wound.
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 Santyl OintmentTopical daily application | Biological | Collagenase Santyl |
| Placebo ComparatorTopical daily application | Other | Vehicle Base |
Primary outcome
Change From Baseline in Extent of Presence/Absence of Epithelial Tongue.
Time frame: 28 Days
The results were found to be inconclusive due to the small number of biopsy specimens of sufficient quality for analysis. Four of the 10 subjects enrolled were not evaluable due to poor biopsy quality.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert B Slade, MD study chair
Healthpoint
Art J Tallis, DPM principal investigator
Associated Foot & Ankle Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collagenase Santyl Ointment in people with Diabetic Foot Ulcers and Diabetic Foot Wounds, run by Healthpoint 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 23 inclusion and 8 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 30 May 2013. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2013). 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?
Change From Baseline in Extent of Presence/Absence of Epithelial Tongue. (time frame: 28 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 30 May 2013.