Diabetic Foot UlcersPhase 4NCT01056198
Santyl vs. Sharp Debridement of Diabetic Foot Wounds
A Phase 4 study testing Santyl in people with Diabetic Foot Ulcers and Foot Wounds, run by Healthpoint at 9 sites in United States.
Trial summary
This study tests two different approaches to the removal of dead tissue from the surface of a wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers, Foot Wounds
- What is being tested?
- Santyl
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2010to Nov 2011
- 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
- The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
- Subjects 18 years of age or older. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the investigator, will not interfere with the study assessments.
- Willing to make all required study visits.
- Able to follow instructions and perform the dressing changes at home, or, have a caregiver who can perform the dressing changes according to the protocol.
- Willing to use the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase.
- A history of Type I or Type II Diabetes Mellitus requiring insulin or oral hypoglycemic medications to normalize blood glucose levels.
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- A foot wound which is:
- Superficial, involving the full skin thickness but not underlying tissues and is 0.5 cm2 to 10 cm2 in measured surface area at screening visit (not yet debrided)
- Chronic, defined as open for 30 days
- On a neuropathic foot, defined as inability to perceive 10 grams pressure using a Semmes-Weinstein 5.07 or equivalent monofilament in the periwound area
- Adequately perfused, defined as TcPO2 > 40 mmHg; or toe pressure > 40 mmHg, or Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at screening.
- Acceptable state of health and nutrition with:
- Serum albumin ≥ 2.0 g/dL (20g/L)
- Pre-albumin levels of ≥ 15 mg/dL (0.15g/L).
- Per Screening lab chemistry† report:
- Alkaline phosphatase <500 U/L
- Alanine aminotransferase (ALT) <200 U/L
- Aspartate aminotransferase (AST) <175 U/L
- Serum total bilirubin <3.0 mg/dL
- Serum blood urea nitrogen (BUN) < 75 mg/dL
- Serum creatinine 4.5 mg/dL
- HbA1c 12%
- Per Screening lab hematology† report:
- Hemoglobin (Hgb) > 8.0 g/dL
- White blood cells (WBC) > 2.0 109/L
- Absolute neutrophil count > 1.0 109/L
- Platelet count > 50 109/L.
- Local laboratories will be used, but the ranges for inclusion are set based on Healthpoint Data Management ranges. Refer to Appendix 18.1.2.
Who cannot join
- Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels).
- Target wound does not require debridement, or is covered with dry eschar.
- Uncontrolled bleeding disorder.
- Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
- Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia).
- Any of the following:
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- Target wound tunneling per probing and visual assessment
- Osteomyelitis of the target foot or wound probes to bone
- Target wound is on the heel
- Target wound is over a Charcot deformity which cannot be offloaded.
- Diagnosis of chronic granulomatous disease, leukocyte adhesion defects or severe neutropenia
- Treatment with any of the following:
- Systemic corticosteroids
- Immunosuppressive agent(s)
- Chemotherapeutic agent(s)
- Antiviral agent(s)
- Platelet-derived growth factor
- Living skin equivalent
- Dermal substitute
- Radiation therapy to the target lower extremity within 30 days prior to signing the informed consent document.
- Currently on systemic antibiotic therapy
- Any medical condition judged by the Medical Monitor and/or Investigator to cause the study to be detrimental to the subject (specify on the reason for screen failure if this applies).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Advanced Regional Center for Ankle and Foot Care
Altoona, Pennsylvania, 16602
Arlington Research Center
Arlington, Texas, 76011
UNTHSC Fort Worth
Fort Worth, Texas, 76107
St. Mary Medical Center
Langhorne, Pennsylvania, 19047
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19103
Foot Research
Phoenix, Arizona, 85015
Robert Wunderlich
San Antonio, Texas, 78212
Providence Health Center
Waco, Texas, 76712
About this study
Official title: Comparison of Sharp Surgical Debridement Versus Collagenase Santyl Ointment in the Care of Diabetic Foot Wounds
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
- Conditions
- Diabetic Foot Ulcers, Foot Wounds
- Being tested
- Santyl, Control
- Keywords
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SantylDrug
2 mm Santyl applied once daily.
ControlProcedure or surgery
Daily gauze and optional sharp debridement
| Study group | Role | What they receive |
|---|---|---|
| Santyl | Active comparator | 2 mm Santyl applied once daily Receives: Drug: Santyl |
| Control | Sham comparator | Daily gauze and optional sharp debridement Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bates-Jensen Wound Assessment Score - Modified (BWAT-m)
The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).
Measured: baseline and 28 days
Secondary outcomes (2)
Percent of Wound Area Change From Baseline at End of Treatment
Measured: baseline and 28 days
Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up
Measured: baseline and 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionNov 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Healthpoint
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert B Slade, MD, Study chair, Healthpoint, Ltd.Herbert B Slade, MD, Study director, Healthpoint, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056198
- Sponsor's protocol ID
- 017-101-09-028
- Status last verified
- Oct 2012
- First submitted
- 25 Jan 2010
- Last updated
- 21 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB; Collagenase Diabetic Foot Ulcer Study Group. Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study. Clin Ther. 2013 Nov;35(11):1805-20. doi: 10.1016/j.clinthera.2013.09.013. Epub 2013 Oct 18.
PubMed 24145042
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sharp Surgical Debridement Versus Collagenase Santyl Ointment in the Care of Diabetic Foot Wounds
- ClinicalTrials.gov ID
- NCT01056198
- Acronym / sponsor ID
- 017-101-09-028
- Conditions
- Diabetic Foot Ulcers, Foot Wounds
- Keywords
- Diabetic Foot Ulcers, Diabetic Foot Wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Posted 21 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests two different approaches to the removal of dead tissue from the surface of a wound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Santyl | Active comparator | Drug: Santyl2 mm Santyl applied once daily |
| Control | Sham comparator | Procedure: ControlDaily gauze and optional sharp debridement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- The informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. In addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting Visit 1. A photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart.
- Subjects 18 years of age or older. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the investigator, will not interfere with the study assessments.
- Willing to make all required study visits.
- Able to follow instructions and perform the dressing changes at home, or, have a caregiver who can perform the dressing changes according to the protocol.
- Willing to use the Darco (orthopedic) shoe off-loading device and insole, if appropriate, starting on the day of screening and running through the follow-up phase.
Key exclusion criteria (22 listed)
- Contraindications or hypersensitivity to the use of the study medications or their components (refer to product labels).
- Target wound does not require debridement, or is covered with dry eschar.
- Uncontrolled bleeding disorder.
- Untreated cellulitis extending >2 cm around the target wound, untreated lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone.
- Infection in a patient with systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, severe hyperglycemia, or azotemia).
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 |
|---|---|---|
| Santyl2 mm Santyl applied once daily. | Drug | Santyl |
| ControlDaily gauze and optional sharp debridement | Procedure or surgery | Control |
Primary outcome
Bates-Jensen Wound Assessment Score - Modified (BWAT-m)
Time frame: baseline and 28 days
The Bates-Jensen Wound Assessment Score was used to collect information about the wound bed appearance in each of 8 categories (sub-scales) each with a possible score of 1 to 5. For each sub-scale intact skin was scored a one (1) while a five (5) would indicate the worst possible rating. All scores were combined to compute a total score for each arm/group, with a score of 8 indicating intact skin (minimum summed score), and a score of 40 indicating the worst possible rating (maximum summed score).
2 secondary outcomes
Percent of Wound Area Change From Baseline at End of Treatment
Time frame: baseline and 28 days
Percent of Wound Area Change From Baseline at the End of 12 Week Follow-up
Time frame: baseline and 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24145042Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB; Collagenase Diabetic Foot Ulcer Study Group. Clinical and economic assessment of diabetic foot ulcer debridement with collagenase: results of a randomized controlled study. Clin Ther. 2013 Nov;35(11):1805-20. doi: 10.1016/j.clinthera.2013.09.013. Epub 2013 Oct 18.
Related trials for Diabetic Foot Ulcers
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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, Ltd.
Herbert B Slade, MD study director
Healthpoint, Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Santyl in people with Diabetic Foot Ulcers and Foot Wounds, run by Healthpoint at 9 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 28 inclusion and 22 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 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. 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 21 Nov 2012). 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?
Bates-Jensen Wound Assessment Score - Modified (BWAT-m) (time frame: baseline and 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01056198, which also lists 1 linked publication.
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 21 Nov 2012.