Diabetic Foot Ulcers
Conditions
Brief summary
This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.
Interventions
DRUGSantyl
Apply one 24-hr period sufficient to cover the wound.
DRUGTegaderm Hydrogel
Apply once 24-hr period sufficient to cover the wound.
Sponsors
Healthpoint
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 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. * Of either sex, aged 18 years or older. * A diagnosis of Diabetes Mellitus, Type I or II, requiring medication to control blood glucose levels. * A qualifying ulcer, defined as follows: * Ulcer grade 1 or 2 on the Wagner Classification Scale (refer to Section 9.4.1) * Infection / inflammation grade 1 or 2 for wound bed inflammation (refer to Section 9.4.2) * Has not been treated or has not responded to treatment during the past 30 days * Has an apparent area ≥ 3.0 cm² * Requires debridement of the wound bed * Is sufficiently moist to allow collection of wound fluid using a filter paper disc * Adequate arterial blood flow evidenced by ankle brachial index (ABI) of ≥ 0.7 and ≤ 1.1; if the ABI is greater than 1.1, then toe pressure of \>50 mmHg. * Subject must be willing to use the Darco shoe off-loading device and insole, or a comparable device, as indicated. * Subject able to follow instructions, particularly regarding the application of test articles and dressings at home. Able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol.
Exclusion criteria
* Contraindications or known hypersensitivity to the test articles or their components. * Cellulitis extending \>2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone. * Target ulcer tunneling per probing and visual assessment. * Use of systemic antibiotics or any drug listed in Section 9.1.6 of this protocol within 10 days of SCR visit. * Concomitant illness or condition which, in the opinion of the Principal - Investigator, places the subject at risk for this study. * The Medical Monitor may declare any subject ineligible for a valid procedural or medical reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Appearance | 28 days | Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue. |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in Wound Area | 28 days |
Countries
United States
Participant flow
Recruitment details
Adults aged 18 years and older, with Type I or II diabetes mellitus and at least one inflamed diabetic foot ulcer
Participants by arm
| Arm | Count |
|---|---|
| Collagenase Santyl Ointment Santyl
Santyl : Applied once every 24-hr period sufficient to cover the wound. | 9 |
| Control Tegaderm Hydrogel
Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound. | 8 |
| Total | 17 |
Baseline characteristics
| Characteristic | Control | Collagenase Santyl Ointment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age Continuous | 58.0 years STANDARD_DEVIATION 17.8 | 61.4 years STANDARD_DEVIATION 15.3 | 59.8 years STANDARD_DEVIATION 16.1 |
| Region of Enrollment United States | 8 participants | 9 participants | 17 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 9 | 3 / 8 |
| serious Total, serious adverse events | 1 / 9 | 1 / 8 |
Outcome results
Primary
Wound Appearance
Weekly wound appearance as assessed by BWAT-m scores. BWAT-m scores used to determine primary efficacy consist of 8 subscales, each grade an aspect of wound status on a 1-5 scale; 1=normal intact skin; 5=least desirable. Total score=8-40. Subscales: Edges, Undermining, Necrotic Tissue Type, Necrotic Tissue Amount, Exudate Type, Exudate Amount, Skin Color Surrounding Wound, and Granulation Tissue.
Time frame: 28 days
Population: 12 subjects initially for this exploratory study. 17 subjects enrolled to ensure 12 evaluable. Intent-to-treat used for primary inference. Missing values imputed by method of population mean (BWAT-m) and last observation carried forward (wound area).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collagenase Santyl Ointment | Wound Appearance | Baseline | 19 units on a scale | Standard Deviation 5.4 |
| Collagenase Santyl Ointment | Wound Appearance | Week 4 | 16.9 units on a scale | Standard Deviation 7.6 |
| Control | Wound Appearance | Baseline | 19 units on a scale | Standard Deviation 1.8 |
| Control | Wound Appearance | Week 4 | 14.5 units on a scale | Standard Deviation 5.4 |
Secondary
Percent Change in Wound Area
Time frame: 28 days
Population: Intent-to-Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Collagenase Santyl Ointment | Percent Change in Wound Area | -69.9 percentage change from baseline area | Standard Deviation 39 |
| Control | Percent Change in Wound Area | -41.6 percentage change from baseline area | Standard Deviation 105 |