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The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute. The commercially available product is Helicoll® Advanced Skin Substitute.
In this trial two groups of subjects with Wagner 1 diabetic foot ulcers (DFUs), will receive standard of care (SOC) treatment for their condition. Half of the patients will have their SOC treatment with Epifix® or Grafix® and the other half will receive a 510K FDA cleared Helicoll® Advanced Skin Substitute as the primary treatment. The primary endpoint is the percentage wound area reduction of the target ulcer. Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period, the time to achieve complete wound closure of the target ulcer by the end of 5 weeks, and mean number of IP applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC and Advanced Bioengineered Skin Substitute | Other | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). |
|
| SOC and Active Comparator | Other | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC and Advanced Bioengineered Skin Substitute | Device | SOC primary dressing with Helicoll® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Wound Area Reduction | Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Repeated Applications | Number of Participants with repeated applications of the Advanced Skin Substitute used to obtain wound closure | 4 weeks |
| Proportion of Complete Closure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Analysis for Treatment Emergent Adverse Events | The number and type of Treatment Emergent Adverse Events | 5 weeks |
Inclusion Criteria:
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus.
At randomization, subjects must have a target diabetic foot ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 10.0 cm2 measured post debridement using a ruler to measure wound area.
The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.
The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
The target ulcer must be full thickness on the foot or ankle that does not probe to bone.
Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit:
If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
The subject must consent to using the prescribed off-loading method for the duration of the study.
The subject must agree to attend the twice-weekly/weekly study visits required by the protocol.
The subject must be willing and able to participate in the informed consent process.
Patients must have read and signed the IRB approved ICF before screening procedures are undertaken.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clemente Clinical Research | Los Angeles | California | 90033 | United States | ||
| Doctors Research Network |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC and Advanced Bioengineered Skin Substitute | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2024 | Nov 17, 2024 |
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| SOC and Active Comparator | Other | SOC primary dressing with Epifix® or Grafix® |
|
The proportion of subjects that obtain complete closure over the 5-week treatment period
| 5 weeks |
| Time to Achieve Complete Wound Closure | The time to achieve complete wound closure of the target ulcer by the end of 5 weeks | 5 weeks |
| South Miami |
| Florida |
| 33143 |
| United States |
| Foot and Ankle Specialists of the Mid-Atlantic | Salem | Virginia | 24153 | United States |
| FG001 | SOC and Active Comparator | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix® |
| COMPLETED |
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| NOT COMPLETED |
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Per-Protocol (PP) Population (All Randomized Subjects)
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| ID | Title | Description |
|---|---|---|
| BG000 | SOC and Advanced Bioengineered Skin Substitute | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll® |
| BG001 | SOC and Active Comparator | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix® |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Smoker | Count of Participants | Participants |
| ||||||||||||||||
| HbA1c | Mean | Standard Deviation | Percentage |
| |||||||||||||||
| Creatinine | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Years of DFUs | Mean | Standard Deviation | years |
| |||||||||||||||
| Prior DFU count | Mean | Standard Deviation | Count of Ulcer |
| |||||||||||||||
| Other concurrent DFUs (at screening) | Count of Participants | Participants |
| ||||||||||||||||
| History DFU recurrence | Count of Participants | Participants |
| ||||||||||||||||
| Amputations, Minor | Count of Participants | Participants |
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| Major amputations | Count of Participants | Participants |
| ||||||||||||||||
| Foot deformities | Count of Participants | Participants |
| ||||||||||||||||
| Wound area | Mean | Standard Deviation | cm2 |
| |||||||||||||||
| Wound age | Mean | Standard Deviation | Weeks |
| |||||||||||||||
| Vertical location | Count of Participants | Participants |
| ||||||||||||||||
| DFU position | Count of Participants | Participants |
| ||||||||||||||||
| Anatomical location | Count of Participants | Participants |
| ||||||||||||||||
| History offloading type | Count of Participants | Participants |
| ||||||||||||||||
| Number of sharp debridements | Mean | Standard Deviation | Sharp debridements |
| |||||||||||||||
| Chronic Kidney Disease (CKD) | Count of Participants | Participants |
| ||||||||||||||||
| Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Peripheral Arterial Disease/Peripheral Vascular Disease (PAD/PVD) | Count of Participants | Participants |
| ||||||||||||||||
| Chronic Heart Failure (CHF) | Count of Participants | Participants |
| ||||||||||||||||
| Leg edema | Count of Participants | Participants |
| ||||||||||||||||
| Restricted mobility | Any subject who uses a walker, wheelchair, crutches or canes, and/or has an inability to move freely because of a physical or mental disability, handicap or restriction | Count of Participants | Participants |
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| Venous disease | Count of Participants | Participants |
| ||||||||||||||||
| Peripheral neuropathy | Count of Participants | Participants |
| ||||||||||||||||
| Any psychiatric condition | Count of Participants | Participants |
| ||||||||||||||||
| Comorbidity count | Mean | Standard Deviation | Comorbidities |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Wound Area Reduction | Average Percentage of Wound Area Reduction from Treatment Visit 1 to Treatment Visit 4 measured manually with digital photography | Posted | Mean | Standard Deviation | Percentage of Wound Area Reduction | 4 weeks |
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| Secondary | Number of Participants With Repeated Applications | Number of Participants with repeated applications of the Advanced Skin Substitute used to obtain wound closure | Healed wounds only | Posted | Number | participants | 4 weeks |
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| Secondary | Proportion of Complete Closure | The proportion of subjects that obtain complete closure over the 5-week treatment period | Posted | Count of Participants | Participants | 5 weeks |
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| Secondary | Time to Achieve Complete Wound Closure | The time to achieve complete wound closure of the target ulcer by the end of 5 weeks | Posted | Mean | 95% Confidence Interval | Days | 5 weeks |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Safety Analysis for Treatment Emergent Adverse Events | The number and type of Treatment Emergent Adverse Events | Not Posted | 5 weeks | Participants |
5 weeks
An AE is defined as any unfavorable or unintended sign, symptom or disease that occurs or is reported by the subject to have occurred, or a worsening of a pre-existing condition related to the procedure or medical treatment (device/drug) used.
AEs will be defined as those events that occur after the first study treatment is applied at TV1, through the final study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOC and Advanced Bioengineered Skin Substitute | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Helicoll® applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Advanced Bioengineered Skin Substitute: SOC primary dressing with Helicoll® | 0 | 12 | 0 | 12 | 0 | 12 |
| EG001 | SOC and Active Comparator | The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM boot), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with Epifix® or Grafix® followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous, second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Dynaflex™ or equivalent). SOC and Active Comparator: SOC primary dressing with Epifix® or Grafix® | 0 | 12 | 0 | 12 | 0 | 12 |
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Investigators shall not independently publish, publicly disclose, present or discuss any results or information pertaining to study conducted under the mutual agreement until such a multi-center publication is released under Sponsor's direction.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Subramanian Gunasekaran, PhD | Encoll Corp | +1 (510) 396-8581 | guna@encoll.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2024 | Dec 11, 2024 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| Male |
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| African American |
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| Hispanic |
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| Former |
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| Never smoked |
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| 1 |
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| 2 |
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| 1 |
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| 2 |
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| 5 |
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| Plantar arthrodesis |
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| Ankle tarsal tunnel |
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| No deformities |
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| Dorsal |
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| Lateral |
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| Forefoot |
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| Midfoot |
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| Heel |
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| CAM boot |
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| Surgical shoe |
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