Diabetic Foot Ulcer (DFU)
Conditions
Brief summary
This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers. The study intends to compare patient outcome data using Standard of Care with Type-I Collagen-based Skin Substitute and Standard of Care with Dehydrated Human Amnion/Chorion Membrane.
Detailed description
The purpose of this randomized controlled clinical study is to collect and compare patient outcome data at 4 weeks using Type-I Collagen-based Skin Substitute in one half of the patients and Dehydrated Human Amnion/Chorion Membrane in the other half.
Interventions
Arm 2: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage)
Arm 1 -The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage)
Sponsors
Adichunchanagiri Institute of Medical Sciences, B G Nagara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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: * Transcutaneous Oxygen Measurement (TCOM) ≥30 mmHg * Ankle-Brachial Index (ABI) between 0.7 and 1.3 * Peripheral Vascular Resistance (PVR): Biphasic * Toe-Brachial Index (TBI) ˃0.6 * As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle of the target extremity. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Wound Area Epithelialization From Week 1 Through 4 | 4 weeks | Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period | 4 weeks | The proportion of subjects that obtain complete closure over the 4-week treatment period |
| Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure | 4 Weeks | Percenatge of participants undergoing repeat applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Appearance | The appearance of thewound was assessed only once i.e at the end of 5th week. | Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities. Appearance was assessed using visual analog scale, wherein the scale ratings ranged from 0 to 5 where 0 refers to worst appearance and 5 refers to best appearance |
| Structural Stability of the Scar | The appearance of the woundd was assessed only once i.e. at the end of 5th week. | Structural stability of the healed wound will be assessed by compression testing using a blunt-edged tool. Following assessment by the blunt tool, structural stability was rated on 5 point visual anaog scale, where 1 represents fragile and 5 represents stable wound |
| Wound Recurrence | During 1-week follow-up | Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SOC and Type-I Collagen-based Skin Substitute Arm 1 -The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage)
SOC and Type-I Collagen-based Skin Substitute: Arm 1 -The SOC in this study is wound care covering with High Purity Type-I Collagen-based Skin Substitute applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) | 14 |
| SOC and Human Amnion/Chorion Membrane Arm 2: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage)
SOC and Human Amnion/Chorion Membrane: Arm 2: The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze (Cuticel), second layer - absorbent 4x4 gauze pads & third layer - soft roll and compressive wrap (Crepe Bandage) | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | SOC and Type-I Collagen-based Skin Substitute | SOC and Human Amnion/Chorion Membrane | Total |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 5.98 | 52.3 years STANDARD_DEVIATION 7.16 | 50.9 years STANDARD_DEVIATION 6.63 |
| BMI | 25.4 kg/m^2 STANDARD_DEVIATION 2.28 | 25.3 kg/m^2 STANDARD_DEVIATION 2.08 | 25.4 kg/m^2 STANDARD_DEVIATION 2.11 |
| Doppler Scan Findings Biphasic Flow | 4 Participants | 5 Participants | 9 Participants |
| Doppler Scan Findings Triphasic Flow | 10 Participants | 9 Participants | 19 Participants |
| Glcosylated Hemoglobin | 5.8 mmol/mol STANDARD_DEVIATION 0.27 | 5.8 mmol/mol STANDARD_DEVIATION 0.25 | 5.8 mmol/mol STANDARD_DEVIATION 0.25 |
| Hypertension Hypertension (Absent) | 12 Participants | 11 Participants | 23 Participants |
| Hypertension Hypertension (Present) | 2 Participants | 3 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
| Smoking Smoking (Absent) | 11 Participants | 11 Participants | 22 Participants |
| Smoking Smoking (Present) | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Percentage Wound Area Epithelialization From Week 1 Through 4
Percentage wound area epithelialization from week 1 through 4 measured manually with digital photography. Calculated by using: Percentage Epithelialization=(Epithelialized Area / Total Wound Area)×100
Time frame: 4 weeks
Population: The number given indicates the average change in wound area in both the groups between baseline and week 4. Since in all the study participants the wound area has decreased, the value in the table indicates average decrease in wound area in both the groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Percentage Wound Area Epithelialization From Week 1 Through 4 | 93.62 percentage wound area epithelialization | Standard Deviation 0.12 |
| SOC and Human Amnion/Chorion Membrane | Percentage Wound Area Epithelialization From Week 1 Through 4 | 77.71 percentage wound area epithelialization | Standard Deviation 0.28 |
Secondary
Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure
Percenatge of participants undergoing repeat applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane used to obtain wound closure. Since the participants who underwent repeat applications in both groups had only one repeat application, instead of the mean number of repeat applications we are indicating the percentage of participants having repeat applications in both the groups.
Time frame: 4 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure | 5 Participants |
| SOC and Human Amnion/Chorion Membrane | Percenatge of Participants Undergoing Repeat Applications of Advanced Skin Substitute & Human Amnion/Chorion Membrane Used to Obtain Wound Closure | 4 Participants |
Secondary
Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period
The proportion of subjects that obtain complete closure over the 4-week treatment period
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period | 10 Participants |
| SOC and Human Amnion/Chorion Membrane | Proportion of Subjects That Obtain Complete Closure Over 4-week Treatment Period | 7 Participants |
Other Pre-specified
Appearance
Visual observation of the newly formed skin for signs of redness, swelling and other abnormalities. Appearance was assessed using visual analog scale, wherein the scale ratings ranged from 0 to 5 where 0 refers to worst appearance and 5 refers to best appearance
Time frame: The appearance of thewound was assessed only once i.e at the end of 5th week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Appearance | 2.5 units on a scale | Standard Deviation 0.52 |
| SOC and Human Amnion/Chorion Membrane | Appearance | 2.2 units on a scale | Standard Deviation 0.69 |
Other Pre-specified
Structural Stability of the Scar
Structural stability of the healed wound will be assessed by compression testing using a blunt-edged tool. Following assessment by the blunt tool, structural stability was rated on 5 point visual anaog scale, where 1 represents fragile and 5 represents stable wound
Time frame: The appearance of the woundd was assessed only once i.e. at the end of 5th week.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Structural Stability of the Scar | 3.43 units on a scale | Standard Deviation 1.02 |
| SOC and Human Amnion/Chorion Membrane | Structural Stability of the Scar | 2.71 units on a scale | Standard Deviation 0.91 |
Other Pre-specified
Wound Recurrence
Subject will be observed for any recurrence of the wound after its closure during the 1-week follow-up
Time frame: During 1-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SOC and Type-I Collagen-based Skin Substitute | Wound Recurrence | 1 Participants |
| SOC and Human Amnion/Chorion Membrane | Wound Recurrence | 2 Participants |