Diabetic Foot, Diabetic Foot Ulcer, Ulcer Foot
Conditions
Keywords
DFU, Ulcer
Brief summary
This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available treatments for diabetic foot wounds.
Detailed description
This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment. There are two arms in the study: Arm 1: SOC therapy (offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with resorbable bioactive glass fiber, MIRRAGEN™ Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent). ARM 2: SOC therapy (offloading of the DFU (CAM boots or total contact casting \[TCC\] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement)) and wound care covering with calcium alginate Fibracol dressing follwed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent).
Interventions
DEVICEMirragen Advanced Wound Matrix
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional outer dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Mirragen Advanced Wound Matrix - application of Mirragen to wound site along with standard of care treatment.
DEVICEFibracol
Offloading - patient will be offloaded in a diabetic CAM boot after treatment, or total contact cast if patient cannot be fit in a diabetic boot. Other names; pressure relief. Additional outer dressing application - application of outer moisture retentive dressing, and a multilayer compression dressing. Other names; outer protective dressing. Fibracol - application of Fibracol to wound site along with standard of care treatment.
Sponsors
Professional Education and Research Institute
ETS Wound Care, LLC
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
1. Subjects must be at least 18 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus. 3. 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 20.0 cm2 measured post debridement with a photographic planimetry app. 4. 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. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be full thickness on the foot or ankle that does not probe to bone. 7. Adequate circulation to the affected foot as documented by any of the following methods performed within 3 months of the first screening visit: 1. TCOM ≥30 mmHg 2. ABI between 0.7 and 1.3 3. PVR: Biphasic 4. TBI ˃0.6 5. As an alternative arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle 8. 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. 9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to randomization. 10. The subject must consent to using the prescribed off-loading method for the duration of the study. 11. The subject must agree to attend the weekly study visits required by the protocol. 12. The subject must be willing and able to participate in the informed consent process.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing | 12 weeks | The proportion of subjects achieving complete wound closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Area Reduction (PAR) | 12 weeks | Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination |
| Time to Heal | 12 weeks | The time to achieve complete wound closure within 12 weeks. |
| Changes in Quality of Life | 12 weeks | The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes. |
| Change in Pain Level | 12 weeks | The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain. |
Countries
United States
Participant flow
Pre-assignment details
245 subjects were assessed for eligibility to participate in the study.
Participants by arm
| Arm | Count |
|---|---|
| SOC Primary Dressing With MIRRAGEN™ Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. | 67 |
| SOC Primary Dressing With FIBRACOL™ A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. | 66 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up | Adverse Event | 4 | 2 |
| Follow-up | Death | 1 | 0 |
| Follow-up | Lost to Follow-up | 1 | 0 |
| Follow-up | Other reasons | 0 | 4 |
| Follow-up | Withdrawal by Subject | 2 | 3 |
| Follow-up | Withdrawn per protocol with PAR <50% at week 6 | 17 | 19 |
Baseline characteristics
| Characteristic | SOC Primary Dressing With FIBRACOL™ | Total | SOC Primary Dressing With MIRRAGEN™ |
|---|---|---|---|
| Age, Continuous mITT | 59.1 years STANDARD_DEVIATION 14.26 | 59.6 years STANDARD_DEVIATION 15.5 | 60.1 years STANDARD_DEVIATION 16.81 |
| Age, Continuous PP | 57.7 years STANDARD_DEVIATION 15.6 | 59.1 years STANDARD_DEVIATION 15.95 | 60.2 years STANDARD_DEVIATION 16.34 |
| Age when first DFU appeared mITT | 53.6 years STANDARD_DEVIATION 11.6 | 55.9 years STANDARD_DEVIATION 11.76 | 58.2 years STANDARD_DEVIATION 11.56 |
| Age when first DFU appeared PP | 54.4 years STANDARD_DEVIATION 11.09 | 56.8 years STANDARD_DEVIATION 11.66 | 58.9 years STANDARD_DEVIATION 11.86 |
| BMI mITT | 35.0 kg/m² STANDARD_DEVIATION 8.98 | 34.5 kg/m² STANDARD_DEVIATION 8.71 | 33.9 kg/m² STANDARD_DEVIATION 8.45 |
| BMI PP | 36.4 kg/m² STANDARD_DEVIATION 9.99 | 35.3 kg/m² STANDARD_DEVIATION 9.5 | 34.3 kg/m² STANDARD_DEVIATION 9.06 |
| Comorbidities: any psychiatric condition mITT | 22 Participants | 39 Participants | 17 Participants |
| Comorbidities: any psychiatric condition PP | 13 Participants | 26 Participants | 13 Participants |
| Comorbidities: chronic heart failure (CHF) mITT | 3 Participants | 7 Participants | 4 Participants |
| Comorbidities: chronic heart failure (CHF) PP | 2 Participants | 6 Participants | 4 Participants |
| Comorbidities: chronic kidney disease (CKD) mITT | 11 Participants | 15 Participants | 4 Participants |
| Comorbidities: chronic kidney disease (CKD) PP | 5 Participants | 8 Participants | 3 Participants |
| Comorbidities: gastroesophageal reflux disease (GERD) mITT | 17 Participants | 30 Participants | 13 Participants |
| Comorbidities: gastroesophageal reflux disease (GERD) PP | 7 Participants | 18 Participants | 11 Participants |
| Comorbidities: hyperlipidemia / dyslipidemia mITT | 24 Participants | 44 Participants | 20 Participants |
| Comorbidities: hyperlipidemia / dyslipidemia PP | 11 Participants | 25 Participants | 14 Participants |
| Comorbidities: hypertension mITT | 49 Participants | 90 Participants | 41 Participants |
| Comorbidities: hypertension PP | 25 Participants | 50 Participants | 25 Participants |
| Comorbidities: hypothyroidism mITT | 11 Participants | 20 Participants | 9 Participants |
| Comorbidities: hypothyroidism PP | 6 Participants | 13 Participants | 7 Participants |
| Comorbidities: lower extremity edema mITT | 6 Participants | 10 Participants | 4 Participants |
| Comorbidities: lower extremity edema PP | 1 Participants | 5 Participants | 4 Participants |
| Comorbidities: peripheral arterial disease (PAD) / peripheral vascular disease (PVD) mITT | 5 Participants | 12 Participants | 7 Participants |
| Comorbidities: peripheral arterial disease (PAD) / peripheral vascular disease (PVD) PP | 5 Participants | 10 Participants | 5 Participants |
| Comorbidities: peripheral neuropathy mITT | 34 Participants | 61 Participants | 27 Participants |
| Comorbidities: peripheral neuropathy PP | 17 Participants | 36 Participants | 19 Participants |
| Creatinine mITT | 1.24 mg/dL STANDARD_DEVIATION 0.54 | 1.2 mg/dL STANDARD_DEVIATION 0.49 | 1.09 mg/dL STANDARD_DEVIATION 0.42 |
| Creatinine PP | 1.19 mg/dL STANDARD_DEVIATION 0.46 | 1.1 mg/dL STANDARD_DEVIATION 0.46 | 1.09 mg/dL STANDARD_DEVIATION 0.46 |
| Diabetes duration mITT | 15.9 years STANDARD_DEVIATION 9.58 | 16.5 years STANDARD_DEVIATION 11.71 | 17.1 years STANDARD_DEVIATION 13.59 |
| Diabetes duration PP | 16.4 years STANDARD_DEVIATION 14.18 | 16.0 years STANDARD_DEVIATION 11.93 | 15.7 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) mITT Hispanic or Latino | 14 Participants | 33 Participants | 19 Participants |
| Ethnicity (NIH/OMB) mITT Not Hispanic or Latino | 52 Participants | 100 Participants | 48 Participants |
| Ethnicity (NIH/OMB) mITT Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) PP Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) PP Not Hispanic or Latino | 29 Participants | 63 Participants | 34 Participants |
| Ethnicity (NIH/OMB) PP Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| HbA1c mITT | 7.4 % STANDARD_DEVIATION 1.65 | 7.6 % STANDARD_DEVIATION 1.67 | 7.7 % STANDARD_DEVIATION 1.69 |
| HbA1c PP | 7.4 % STANDARD_DEVIATION 1.57 | 7.6 % STANDARD_DEVIATION 1.6 | 7.7 % STANDARD_DEVIATION 1.61 |
| History of DFU recurrence mITT | 31 Participants | 63 Participants | 32 Participants |
| History of DFU recurrence PP | 16 Participants | 34 Participants | 18 Participants |
| Major amputation mITT | 5 Participants | 7 Participants | 2 Participants |
| Major amputation PP | 4 Participants | 5 Participants | 1 Participants |
| Major foot deformities mITT Cavus foot | 1 Participants | 4 Participants | 3 Participants |
| Major foot deformities mITT Charcot | 8 Participants | 13 Participants | 5 Participants |
| Major foot deformities mITT Hallux valgis | 1 Participants | 3 Participants | 2 Participants |
| Major foot deformities mITT Hammertoe | 1 Participants | 3 Participants | 2 Participants |
| Major foot deformities mITT None of the above | 55 Participants | 109 Participants | 54 Participants |
| Major foot deformities mITT Varus ankle | 0 Participants | 1 Participants | 1 Participants |
| Major foot deformities PP Cavus foot | 1 Participants | 3 Participants | 2 Participants |
| Major foot deformities PP Charcot | 4 Participants | 5 Participants | 1 Participants |
| Major foot deformities PP Hallux valgis | 1 Participants | 3 Participants | 2 Participants |
| Major foot deformities PP Hammertoe | 1 Participants | 2 Participants | 1 Participants |
| Major foot deformities PP None of the above | 31 Participants | 69 Participants | 38 Participants |
| Major foot deformities PP Varus ankle | 0 Participants | 0 Participants | 0 Participants |
| Minor amputations mITT 0 | 37 Participants | 78 Participants | 41 Participants |
| Minor amputations mITT 1 | 14 Participants | 25 Participants | 11 Participants |
| Minor amputations mITT 2 | 7 Participants | 12 Participants | 5 Participants |
| Minor amputations mITT 3 or more | 8 Participants | 18 Participants | 10 Participants |
| Minor amputations PP 0 | 21 Participants | 52 Participants | 31 Participants |
| Minor amputations PP 1 | 10 Participants | 16 Participants | 6 Participants |
| Minor amputations PP 2 | 3 Participants | 6 Participants | 3 Participants |
| Minor amputations PP 3 or more | 4 Participants | 8 Participants | 4 Participants |
| Number of comorbidities mITT | 7.9 comorbidities STANDARD_DEVIATION 4.29 | 7.5 comorbidities STANDARD_DEVIATION 4.92 | 7.1 comorbidities STANDARD_DEVIATION 5.48 |
| Number of comorbidities PP | 8.0 comorbidities STANDARD_DEVIATION 4.32 | 7.1 comorbidities STANDARD_DEVIATION 4.47 | 6.3 comorbidities STANDARD_DEVIATION 4.5 |
| Number of debridements mITT | 9.2 debridements STANDARD_DEVIATION 3.34 | 9.1 debridements STANDARD_DEVIATION 3.43 | 9.0 debridements STANDARD_DEVIATION 3.54 |
| Number of debridements PP | 9.7 debridements STANDARD_DEVIATION 3.85 | 9.6 debridements STANDARD_DEVIATION 3.96 | 9.4 debridements STANDARD_DEVIATION 4.09 |
| Number of other concurrent DFUs at screening mITT 0 | 53 Participants | 101 Participants | 48 Participants |
| Number of other concurrent DFUs at screening mITT 1 | 0 Participants | 1 Participants | 1 Participants |
| Number of other concurrent DFUs at screening mITT 2 | 9 Participants | 24 Participants | 15 Participants |
| Number of other concurrent DFUs at screening mITT 3 or more | 4 Participants | 7 Participants | 3 Participants |
| Number of other concurrent DFUs at screening PP 0 | 29 Participants | 61 Participants | 32 Participants |
| Number of other concurrent DFUs at screening PP 1 | 0 Participants | 0 Participants | 0 Participants |
| Number of other concurrent DFUs at screening PP 2 | 7 Participants | 18 Participants | 11 Participants |
| Number of other concurrent DFUs at screening PP 3 or more | 2 Participants | 3 Participants | 1 Participants |
| Number of participants with index wound in each anatomical location mITT Ankle | 3 Participants | 5 Participants | 2 Participants |
| Number of participants with index wound in each anatomical location mITT Forefoot | 24 Participants | 53 Participants | 29 Participants |
| Number of participants with index wound in each anatomical location mITT Heel | 10 Participants | 19 Participants | 9 Participants |
| Number of participants with index wound in each anatomical location mITT Hindfoot | 2 Participants | 4 Participants | 2 Participants |
| Number of participants with index wound in each anatomical location mITT Midfoot | 17 Participants | 29 Participants | 12 Participants |
| Number of participants with index wound in each anatomical location mITT Toe | 10 Participants | 23 Participants | 13 Participants |
| Number of participants with index wound in each anatomical location PP Ankle | 3 Participants | 4 Participants | 1 Participants |
| Number of participants with index wound in each anatomical location PP Forefoot | 15 Participants | 33 Participants | 18 Participants |
| Number of participants with index wound in each anatomical location PP Heel | 6 Participants | 12 Participants | 6 Participants |
| Number of participants with index wound in each anatomical location PP Hindfoot | 1 Participants | 2 Participants | 1 Participants |
| Number of participants with index wound in each anatomical location PP Midfoot | 7 Participants | 12 Participants | 5 Participants |
| Number of participants with index wound in each anatomical location PP Toe | 6 Participants | 19 Participants | 13 Participants |
| Number of participants with index wound in each position mITT Lateral | 28 Participants | 60 Participants | 32 Participants |
| Number of participants with index wound in each position mITT Medial | 37 Participants | 72 Participants | 35 Participants |
| Number of participants with index wound in each position mITT Unknown | 1 Participants | 1 Participants | 0 Participants |
| Number of participants with index wound in each position PP Lateral | 17 Participants | 35 Participants | 18 Participants |
| Number of participants with index wound in each position PP Medial | 20 Participants | 46 Participants | 26 Participants |
| Number of participants with index wound in each position PP Unknown | 1 Participants | 1 Participants | 0 Participants |
| Number of participants with index wound in each vertical location mITT Dorsal | 12 Participants | 27 Participants | 15 Participants |
| Number of participants with index wound in each vertical location mITT Plantar | 54 Participants | 106 Participants | 52 Participants |
| Number of participants with index wound in each vertical location PP Dorsal | 9 Participants | 19 Participants | 10 Participants |
| Number of participants with index wound in each vertical location PP Plantar | 29 Participants | 63 Participants | 34 Participants |
| Number of prior DFUs mITT | 4.4 DFUs STANDARD_DEVIATION 4.96 | 3.8 DFUs STANDARD_DEVIATION 4.66 | 3.1 DFUs STANDARD_DEVIATION 4.27 |
| Number of prior DFUs PP | 3.6 DFUs STANDARD_DEVIATION 3.77 | 3.0 DFUs STANDARD_DEVIATION 3.38 | 2.5 DFUs STANDARD_DEVIATION 2.95 |
| Off-loading type mITT Boot | 11 Participants | 21 Participants | 10 Participants |
| Off-loading type mITT CAM boot | 31 Participants | 59 Participants | 28 Participants |
| Off-loading type mITT No off-loading | 13 Participants | 27 Participants | 14 Participants |
| Off-loading type mITT Other | 2 Participants | 7 Participants | 5 Participants |
| Off-loading type mITT Shoe | 9 Participants | 19 Participants | 10 Participants |
| Off-loading type PP Boot | 10 Participants | 16 Participants | 6 Participants |
| Off-loading type PP CAM boot | 14 Participants | 35 Participants | 21 Participants |
| Off-loading type PP No off-loading | 9 Participants | 19 Participants | 10 Participants |
| Off-loading type PP Other | 2 Participants | 5 Participants | 3 Participants |
| Off-loading type PP Shoe | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) mITT American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) mITT Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) mITT Black or African American | 4 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) mITT More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) mITT Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) mITT Unknown or Not Reported | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) mITT White | 60 Participants | 117 Participants | 57 Participants |
| Race (NIH/OMB) PP American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) PP Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) PP More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) PP Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) PP White | 34 Participants | 71 Participants | 37 Participants |
| Sex: Female, Male mITT Female | 18 Participants | 38 Participants | 20 Participants |
| Sex: Female, Male mITT Male | 48 Participants | 95 Participants | 47 Participants |
| Sex: Female, Male PP Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male PP Male | 29 Participants | 62 Participants | 33 Participants |
| Tobacco use mITT Current | 8 Participants | 21 Participants | 13 Participants |
| Tobacco use mITT Former | 22 Participants | 42 Participants | 20 Participants |
| Tobacco use mITT Never used tobacco | 36 Participants | 70 Participants | 34 Participants |
| Tobacco use PP Current | 4 Participants | 12 Participants | 8 Participants |
| Tobacco use PP Former | 15 Participants | 28 Participants | 13 Participants |
| Tobacco use PP Never used tobacco | 19 Participants | 42 Participants | 23 Participants |
| Wound age mITT | 20.9 weeks STANDARD_DEVIATION 14.82 | 20.9 weeks STANDARD_DEVIATION 14 | 20.9 weeks STANDARD_DEVIATION 13.26 |
| Wound age PP | 21.3 weeks STANDARD_DEVIATION 14.55 | 20.3 weeks STANDARD_DEVIATION 13.69 | 19.4 weeks STANDARD_DEVIATION 12.99 |
| Wound area mITT | 3.3 cm^2 STANDARD_DEVIATION 2.57 | 3.2 cm^2 STANDARD_DEVIATION 2.69 | 3.1 cm^2 STANDARD_DEVIATION 2.81 |
| Wound area PP | 3.1 cm^2 STANDARD_DEVIATION 2.43 | 2.9 cm^2 STANDARD_DEVIATION 2.39 | 2.7 cm^2 STANDARD_DEVIATION 2.37 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 67 | 0 / 66 |
| other Total, other adverse events | 5 / 67 | 5 / 66 |
| serious Total, serious adverse events | 6 / 67 | 3 / 66 |
Outcome results
Primary
Complete Wound Healing
The proportion of subjects achieving complete wound closure.
Time frame: 12 weeks
Population: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Complete Wound Healing | mITT | 32 Participants |
| SOC primary dressing with MIRRAGEN™ | Complete Wound Healing | PP | 32 Participants |
| SOC primary dressing with FIBRACOL™ | Complete Wound Healing | mITT | 16 Participants |
| SOC primary dressing with FIBRACOL™ | Complete Wound Healing | PP | 16 Participants |
p-value: 0.007Fisher Exact
Secondary
Change in Pain Level
The FACES pain scale was administered to the clinical trial participants at each visit. The trial participant selected their pain level with a series of faces that correspond to a number between 0 which implies no pain, up to 10 which implies the most severe pain.
Time frame: 12 weeks
Population: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Change in Pain Level | mITT | 0.5 score change [EOS - baseline] | Standard Deviation 2.47 |
| SOC primary dressing with MIRRAGEN™ | Change in Pain Level | PP | 0.9 score change [EOS - baseline] | Standard Deviation 2.24 |
| SOC primary dressing with FIBRACOL™ | Change in Pain Level | mITT | 0.8 score change [EOS - baseline] | Standard Deviation 2.27 |
| SOC primary dressing with FIBRACOL™ | Change in Pain Level | PP | 1.0 score change [EOS - baseline] | Standard Deviation 2.44 |
Secondary
Changes in Quality of Life
The WOUND-Q is a questionnaire measuring outcomes important to patients with chronic wounds. Five of the tool's 13 independently functioning scales (with 5 to 11 items each) were measured in this study. 'Assessment' measures how concerned someone has been with their wound(s). 'Drainage' measures how bothered someone has been by drainage from their wound(s). 'Smell' measures how bothered someone has been by the smell from their wound(s). 'Social' measures the impact of a person's wound(s) on their social life. 'Dressing' measures someone's satisfaction with their wound dressing. For all of these scales, possible responses to each item range from minimum 0 ('not at all') to maximum 4 ('very much'). To score a scale, the raw scores for the set of items in a scale are added together to produce a total raw score. The total raw score for the scale is then converted to a score that ranges from 0 to 100. For all, higher scores represent better outcomes.
Time frame: 12 weeks
Population: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Assessment (PP) | 28.1 units on a scale | Standard Deviation 17.89 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Drainage (mITT) | 16.6 units on a scale | Standard Deviation 22.77 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Drainage (PP) | 25.3 units on a scale | Standard Deviation 19.58 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Social (mITT) | 11.6 units on a scale | Standard Deviation 28.14 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Smell (PP) | 8.1 units on a scale | Standard Deviation 20.73 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Assessment (mITT) | 18.3 units on a scale | Standard Deviation 20.68 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Social (PP) | 17.4 units on a scale | Standard Deviation 29.39 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Dressing (mITT) | 9.0 units on a scale | Standard Deviation 21.08 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Dressing (PP) | 14.2 units on a scale | Standard Deviation 20.85 |
| SOC primary dressing with MIRRAGEN™ | Changes in Quality of Life | Smell (mITT) | 4.5 units on a scale | Standard Deviation 23.06 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Dressing (PP) | 7.7 units on a scale | Standard Deviation 18.55 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Drainage (mITT) | 11.8 units on a scale | Standard Deviation 20.83 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Smell (mITT) | 1.4 units on a scale | Standard Deviation 18.42 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Social (mITT) | 15.2 units on a scale | Standard Deviation 26.27 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Dressing (mITT) | 7.1 units on a scale | Standard Deviation 18.04 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Assessment (PP) | 24.6 units on a scale | Standard Deviation 21.34 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Drainage (PP) | 17.6 units on a scale | Standard Deviation 18.57 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Smell (PP) | 3.4 units on a scale | Standard Deviation 17.59 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Social (PP) | 19.0 units on a scale | Standard Deviation 25.53 |
| SOC primary dressing with FIBRACOL™ | Changes in Quality of Life | Assessment (mITT) | 17.0 units on a scale | Standard Deviation 21.36 |
Secondary
Percentage Area Reduction (PAR)
Percentage wound area reduction measured weekly with digital photographic planimetry and physical examination
Time frame: 12 weeks
Population: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Percentage Area Reduction (PAR) | mITT | 48.8 percent | Standard Deviation 82.81 |
| SOC primary dressing with MIRRAGEN™ | Percentage Area Reduction (PAR) | PP | 93.7 percent | Standard Deviation 15.28 |
| SOC primary dressing with FIBRACOL™ | Percentage Area Reduction (PAR) | mITT | 53.7 percent | Standard Deviation 65.78 |
| SOC primary dressing with FIBRACOL™ | Percentage Area Reduction (PAR) | PP | 89.7 percent | Standard Deviation 25.19 |
p-value: 0.78Mixed Models Analysis
p-value: 0.48Mixed Models Analysis
Secondary
Time to Heal
The time to achieve complete wound closure within 12 weeks.
Time frame: 12 weeks
Population: Both the modified intent-to-treat (mITT) and per protocol (PP) analysis populations are represented.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SOC primary dressing with MIRRAGEN™ | Time to Heal | mITT | 63.4 days |
| SOC primary dressing with MIRRAGEN™ | Time to Heal | PP | 57.5 days |
| SOC primary dressing with FIBRACOL™ | Time to Heal | mITT | 72.5 days |
| SOC primary dressing with FIBRACOL™ | Time to Heal | PP | 67.8 days |
p-value: 0.049Log Rank
p-value: 0.084Log Rank