Diabetes, Foot Ulcer
Conditions
Brief summary
* After determining if subjects meet the criteria to be included in the study they will be randomly placed in either Group 1 or 2 and patient will be blinded from randomization group. * Subjects will walk across a pressure plate to determine different areas of high pressure under the foot. This will be done before the INTEGRA application and at every other follow-up visit. * Both groups will be debrided and have pictures taken in the OR * Group 1 will have Integra Flowable Wound Matrix applied onto the wound in the OR and Group 2 will have the Integra Flowable Wound Matrix applied onto the wound and injected subcutaneously in the OR. * Subjects will be placed in a total contact cast at each visit. If wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.
Interventions
DRUGINTEGRA™ Flowable Matrix (Collagen)
INTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed.
Sponsors
Integra LifeSciences Corporation
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years of age or older 2. Subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation. 3. Subject has Diabetes Mellitus (type 1 or type 2). 4. University of Texas Classification 1A with a wound area measurement ranging between 0.3-4.0cm². 5. Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study.
Exclusion criteria
1. Subjects \< 18 years of age 2. Subject is non-diabetic 3. Subjects who present with wounds of etiology other than diabetes 4. Subject demonstrates increased signs of clinical infection 5. Has active malignant disease of any kind. A subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. 6. University of Texas Classification greater than grade 1A 7. Diabetic plantar foot wounds measuring \>4.0cm² 8. Subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing 9. Subjects participating in any other trials in regards to the diabetic foot ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Decrease in Wound Size | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values. | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Integra Flowable on Wound Bed INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. | 2 |
| INTEGRA Flowable on Wound & Injected Subcutaneously INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once. | 3 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | INTEGRA Flowable on Wound & Injected Subcutaneously | Integra Flowable on Wound Bed | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 5 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 4.58258 | 54.5 years STANDARD_DEVIATION 0.70711 | 50 years STANDARD_DEVIATION 5.24404 |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 2 / 3 |
Outcome results
Primary
Overall Decrease in Wound Size
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integra Flowable on Wound Bed | Overall Decrease in Wound Size | 2 participants |
| INTEGRA Flowable on Wound & Injected Subcutaneously | Overall Decrease in Wound Size | 2 participants |
Secondary
Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integra Flowable on Wound Bed | Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values. | 2 participants |
| INTEGRA Flowable on Wound & Injected Subcutaneously | Decreased Peak Plantar Pressures in Both the Static and Dynamic Phases of Gait as Compared to Pre-operative Pressure Values. | 1 participants |