Diabetic Foot UlcersPhase 4NCT01143714
A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers
A Phase 4 study testing Santyl and White Petrolatum in people with Diabetic Foot Ulcers, run by Healthpoint at 6 sites in United States.
Trial summary
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of… 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?
- Santyl and White Petrolatum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 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
- The informed consent document Photography Release 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 the screening visit. 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.
- Age 18 years and older. Subjects may be of either sex and of any race or skin type.
- Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- they are not breast feeding
- undertake an HCG serum pregnancy test, which must be negative
- they do not intend to become pregnant during the study
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- they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
- Post-menopausal is defined as no period in the previous 12 months Adequate birth control methods are defined as: hormonal-topical, oral, implantable or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
- Willing to make all required study visits and to use the Darco shoe off-loading device and insole.
- Able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test article, or has a caregiver available to apply the test article according to the protocol.
- Have a diabetic foot ulcer, Wagner Grades† 1 or 2, on the plantar surface of the foot.
- Target ulcer present for at least 28 days, but no longer than 18 months, and has failed to close by ≥ 40% during the first 4 weeks of therapy administered during the past 4 to 8 weeks.
- Target ulcer area between 2 and 15 cm², post debridement, if required. 9- Adequate arterial blood flow as evidenced by an ankle brachial index (ABI) of > 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then a toe pressure of > 30 mmHg OR a TcPO2 ≥ 40 mmHg; either secondary measure is acceptable, but if both are obtained, each must meet its respective cutoff.
- 10. Reasonable control of blood glucose, as evidenced by a serum HbA1C ≤ 12% at screening.
- 11.Acceptable state of health and nutrition as evidenced by a serum pre-albumin level ≥ 15 mg/dL (0.15 g/L) and serum albumin ≥ 2.0 g/dL (20 g/L) at screening.
- 12. Hematology values in the following ranges: WBC ≥ 3.0x109/L Hgb ≥ 10.0 g/dL Neutrophils ≥ 1.5x109/L Platelets ≥ 75 x109/L Normal blood smear
- Blood chemistry values and urinalysis in the following ranges (Healthpoint Ranges):
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) Alkaline phosphatase ≤ 2.5 times the ULN Alanine transaminase (ALT) ≤ 2.5 times the ULN Aspartate transaminase (AST) ≤ 2.5 times the ULN Serum creatinine ≤ 1.5 times the ULN Urinalysis: WBC < 4/HPF; RBC < 4/HPF
Who cannot join
- Contraindications or known hypersensitivity to the test articles or their components.
- Therapy with another investigational agent within 30 days, lower extremity angioplasty within 4 weeks, untreated osteomyelitis, or chemotherapy or radiation therapy within 5 years prior to screening.
- Prior therapy of the target wound with Santyl.
- Current therapy with systemic antibiotics to treat a foot ulcer, or prescription topical antibiotics on the target ulcer.
- Target ulcer located over the heel (talus, distal calcaneous, navicular, or cuboid).
- Fracture of bones in the target ulcer foot occurring within the past 3 months.
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- Cellulitis or abscess of the target ulcer foot.
- A positive result from the screening Quantitative Bacteriology (Qbac) biopsy. A wound will be considered infected if the laboratory findings reveal ≥ 106 colony forming units (cfu) per gram of tissue or > 1 beta-hemolytic Streptococcus per gram of tissue.
- Target ulcer tunneling, per probing.
- More than three DFU on the target foot. The target ulcer must be at least 2 cm from another ulcer.
- Concomitant severe burn, immunodeficiency disorder, hematologic disorder, or malignancy (other than non-melanoma skin cancer) beyond the in situ stage.
- Abnormal laboratory values that, in the opinion of the Principal Investigator, place the subject at risk for the study.
- Positive serum HCG pregnancy test.
- The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Boston Medical Center
Boston, Massachusetts, 02118-2309
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60154
Complete Family Foot Care
McAllen, Texas, 98501
The Foot and Ankle Institute of Western Pennsylvania
Pittsburgh, Pennsylvania, 15224
Olive View - UCLA Medical Center
Sylmar, California, 91342
Center for Advanced Wound Care
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Santyl, White Petrolatum
- 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
Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
White PetrolatumOther
Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Santyl |
| B | Placebo comparator | Not described Receives: Other: White Petrolatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wound Area
The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period
Measured: 4 Weeks
Secondary outcomes (1)
Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)
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 posted14 Jun 2010 (estimated)
- Study startJun 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, Care provider, Investigator
- Enrolment
- 57 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143714
- Sponsor's protocol ID
- 017-101-09-024
- Status last verified
- May 2013
- First submitted
- 11 Jun 2010
- Last updated
- 6 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 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Vehicle-Controlled Study to Determine the Effect of Four Weeks of Debridement With Collagenase Santyl Ointment (Santyl) on the Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01143714
- Acronym / sponsor ID
- 017-101-09-024
- Conditions
- Diabetic Foot Ulcers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- HealthpointIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Posted 3 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 purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Santyl |
| B | Placebo comparator | Other: White Petrolatum |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- The informed consent document Photography Release 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 the screening visit. 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.
- Age 18 years and older. Subjects may be of either sex and of any race or skin type.
- Women of child-bearing potential (those who are not premenarchal, not surgically sterilized [hysterectomy or bilateral oophorectomy], or not post-menopausal) may participate in the study if they meet all of the following conditions:
- Post-menopausal is defined as no period in the previous 12 months Adequate birth control methods are defined as: hormonal-topical, oral, implantable or injectable contraceptives; mechanical-spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or, surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use an adequate birth control method as described above for the remainder of the study.
- NOTE: Women who have had a bilateral tubal ligation are not considered to have been surgically sterilized and must agree to the conditions as specified above.
Key exclusion criteria (14 listed)
- Contraindications or known hypersensitivity to the test articles or their components.
- Therapy with another investigational agent within 30 days, lower extremity angioplasty within 4 weeks, untreated osteomyelitis, or chemotherapy or radiation therapy within 5 years prior to screening.
- Prior therapy of the target wound with Santyl.
- Current therapy with systemic antibiotics to treat a foot ulcer, or prescription topical antibiotics on the target ulcer.
- Target ulcer located over the heel (talus, distal calcaneous, navicular, or cuboid).
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 |
|---|---|---|
| SantylApply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. | Drug | A |
| White PetrolatumApply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. | Other | B |
Primary outcome
Change in Wound Area
Time frame: 4 Weeks
The primary efficacy endpoint was the percent change in wound area from baseline to completion of the 4-week treatment phase and the 8-week follow-up period
1 secondary outcome
Number of Sharp Debridements Performed During the 4-week Treatment Phase and the 8-week Follow-up Period (12 Weeks Total)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 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
6 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 and White Petrolatum in people with Diabetic Foot Ulcers, run by Healthpoint at 6 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 19 inclusion and 14 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 6 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 6 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 3 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 in Wound Area (time frame: 4 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 6 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.