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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
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)
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)
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, India
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
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
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
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