Diabetic Foot Ulcer
Conditions
Brief summary
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
Detailed description
The primary objective of this study is to determine the number of successful complete wound closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some secondary objectives of this study include documenting the time course of wound healing and assessing changes in quality of life. The primary cohort is individuals suffering from a diabetic foot ulcer that has not been healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle, and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes with adequate vascular profusion. Subjects will be unable to participate if they have osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are immunocompromised or have an HbA1c level equal to or great than 12%. This is a single-arm study with no Independent Variables. Descriptive data to be collected will include demographics, pathology and medical history. Outcome assessments: * proportion of subjects with 100% epithelialization of wound * SF-36 * Adverse events
Interventions
DEVICEBiologic wound graft
Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix
Sponsors
Miromatrix Medical Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 18 years old or older at time of initial visit * Have Type I or Type II diabetes * Have a neuropathic diabetic foot ulcer with the following characteristics: * Is greater than 1 cm2 and less than or equal to 12 cm2 * Has failed to close following at least 2 treatments with a biologic * Has been present for 90 days or longer * Does not show signs of infection * Is full thickness (Wagner Grade I or II) * Located distal to the malleolus * Depth of less than or equal to 5 mm * No exposed capsule, tendon or bone * No tunneling, undermining or sinus tracts * Not between the toes * Be willing and able to maintain required off-loading of affected limb * Be willing and able to perform necessary dressing changes * Have at least one of the following: * An Ankle-brachial index (ABI) ≥ 0.8 * TcPO2 of ≥ 30 mmHg * A toe pressure of ≥ 50 mmHg
Exclusion criteria
* Be pregnant or be planning to become pregnant during the study * Have had a Chopart's Amputation (or higher) * Have a history of bone cancer of the affected limb * Be undergoing dialysis * Have active osteomyelitis or be receiving treatment for osteomyelitis * Be diagnosed with unstable Charcot Foot on the affected side * Have an HbA1c level of ≥ 12% within the past 90 days * Have another ulcer within 2 cm of the study ulcer * Be immunocompromised or at risk of immunosuppression as determined by the treating investigator * Have a known collagen vascular disease or connective tissue disease * Have received treatment of the study ulcer with a skin substitute product or topical growth factor within the past 4 weeks * Be participating in another medical research study * Have a sensitivity to porcine material
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants | 12 weeks | Percentage of participants with healed ulcers within 12 weeks of treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Closure | 12 weeks | Measures the time from treatment to wound healing |
| Change in Patient's Wound Size | 12 weeks | Gives the mean area that the wound closed per week |
| MIRODERM Applications | 12 weeks | Frequency of MIRODERM applications prior to wound closing |
| Short Form 36 - Mental Component Summary Score | Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks) | Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100. |
| Short Form - 36: Bodily Pain | Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks) | Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100. |
| Short Form F36 - Physical Component Summary Score | Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks) | Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MIRODERM Biologic wound graft: Diabetic foot ulcer was treated with MIRODERM Biologic Wound Matrix | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Infection or Osteomyelitis | 9 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MIRODERM |
|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 9.2 |
| Alcohol Use Daily | 1 Participants |
| Alcohol Use Monthly | 3 Participants |
| Alcohol Use None | 28 Participants |
| Alcohol Use Occasional | 5 Participants |
| Alcohol Use Weekly | 1 Participants |
| Ankle Brachial Index | 1.02 Ratio STANDARD_DEVIATION 0.2 |
| BMI | 31.2 kg/m^2 STANDARD_DEVIATION 6.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| HbA1c | 7.8 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.5 |
| Prior Treatments | 2 Applications |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 38 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 10 Participants |
| Tobacco Use < 1 pack/day | 3 Participants |
| Tobacco Use > 1 pack/day | 1 Participants |
| Tobacco Use None | 34 Participants |
| Wound Age | 41.1 weeks STANDARD_DEVIATION 27.2 |
| Wound Location Forefoot | 14 Participants |
| Wound Location Heel | 7 Participants |
| Wound Location Midfoot | 14 Participants |
| Wound Location Toes | 3 Participants |
| Wound Size Screening | 3.5 cm^2 STANDARD_DEVIATION 3.5 |
| Wound Size Treatment | 3.5 cm^2 STANDARD_DEVIATION 3.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 11 / 53 |
| serious Total, serious adverse events | 2 / 53 |
Outcome results
Primary
Percentage of Participants
Percentage of participants with healed ulcers within 12 weeks of treatment
Time frame: 12 weeks
Population: Per protocol analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MIRODERM | Percentage of Participants | 57.89 Percentage of participants with healed u |
Other Pre-specified
Change in Patient's Wound Size
Gives the mean area that the wound closed per week
Time frame: 12 weeks
Population: Per protocol analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MIRODERM | Change in Patient's Wound Size | 0.30 cm^2 per week | Standard Deviation 0.28 |
Other Pre-specified
MIRODERM Applications
Frequency of MIRODERM applications prior to wound closing
Time frame: 12 weeks
Population: Per protocol analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MIRODERM | MIRODERM Applications | 2.0 Applications |
Other Pre-specified
Short Form - 36: Bodily Pain
Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Bodily Pain which assess aspects of physical pain. The higher the score the better the subject's physical health with respect to feeling pain. Range from 0-100.
Time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Population: Per protocol analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRODERM | Short Form - 36: Bodily Pain | Pre-procedure | 57.5 score on a scale | Standard Deviation 32.2 |
| MIRODERM | Short Form - 36: Bodily Pain | Follow-up | 61.9 score on a scale | Standard Deviation 29 |
p-value: =0.01t-test, 1 sided
Other Pre-specified
Short Form 36 - Mental Component Summary Score
Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Vitality, Role Emotional, Social Functioning, and Mental health which assess aspects of Mental health. These are used to make an overall mental health score, the Mental Component Summary score (MCS). The higher the score the better the subject's mental health. Range from 0-100.
Time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Population: Subjects who's wound healed in 12 weeks or less one without appropriate data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRODERM | Short Form 36 - Mental Component Summary Score | Pre-procedure | 71.0 score on a scale | Standard Deviation 16.9 |
| MIRODERM | Short Form 36 - Mental Component Summary Score | Follow-up | 71.9 score on a scale | Standard Deviation 13.9 |
p-value: =0.63t-test, 1 sided
Other Pre-specified
Short Form F36 - Physical Component Summary Score
Measure Description: The Short-Form 36 (SF-36) is a general health assessment tool comprised of 8 sub-scales including Physical Function, Role Physical, Bodily Pain, and General health which assess aspects of physical health. These are used to make an overall physical health score, the Physical Component Summary score (PCS). The higher the score the better the subject's physical health. Range from 0-100.
Time frame: Baseline (Pre-Procedure) and then at final follow-up (maximum 12 weeks)
Population: Subjects who's ulcer healed in 12 weeks or less two without appropriate data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MIRODERM | Short Form F36 - Physical Component Summary Score | Pre-procedure | 39.0 score on a scale | Standard Deviation 16.7 |
| MIRODERM | Short Form F36 - Physical Component Summary Score | Follow-up | 37.0 score on a scale | Standard Deviation 25.6 |
p-value: =0.71t-test, 1 sided
Other Pre-specified
Time to Closure
Measures the time from treatment to wound healing
Time frame: 12 weeks
Population: Subjects who healed in 12 weeks or less
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MIRODERM | Time to Closure | 8.1 Weeks |