Diabetic Foot Ulcers, Diabetic Foot Wounds
Conditions
Keywords
Diabetic, Foot, Ulcers, Wounds
Brief 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.
Interventions
BIOLOGICALCollagenase Santyl Ointment
Topical daily application
OTHERPlacebo Comparator
Topical daily application
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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). * 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Extent of Presence/Absence of Epithelial Tongue. | 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. |
Countries
United States
Participant flow
Recruitment details
Patients with Type I or II diabetes mellitus and a non-healing foot ulcer including postamputation wounds and wounds on the dorsum of the foot.
Participants by arm
| Arm | Count |
|---|---|
| Collagenase Santyl Ointment Applied once daily
Collagenase Santyl Ointment : Topical daily application | 5 |
| Vehicle Base Applied once daily
Placebo Comparator : Topical daily application | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Vehicle Base | Collagenase Santyl Ointment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 5 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 0 Participants | 4 Participants |
| Age Continuous | 50.6 years STANDARD_DEVIATION 10.2 | 72.4 years STANDARD_DEVIATION 8.3 | 61.5 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 1 / 5 | 0 / 5 |
Outcome results
Primary
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.
Time frame: 28 Days
Population: Goal was to complete 10 subjects in an allocation ratio of 1:1 for Santyl vs. placebo. Since this was an exploratory study, the sample size was arbitrary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collagenase Santyl Ointment | Change From Baseline in Extent of Presence/Absence of Epithelial Tongue. | NA participants |
| Vehicle Base | Change From Baseline in Extent of Presence/Absence of Epithelial Tongue. | NA participants |