This is a randomized controlled clinical investigation in patients suffering from diabetic foot ulcers at multiple centres in India and Bangladesh. The study compares patient outcomes using standard wound care with a High Purity Type-I Collagen-Based Skin Substitute against standard wound care with an Acellular Intact Fish Skin Matrix.
Subjects must be at least 18 years of age or older.
Subjects must have a diagnosis of type 1 or 2 diabetes mellitus.
Diabetic foot ulcer located below the malleoli, Wagner Grade 1 or 2 (University of Texas Grade 1-2), without exposed bone.
Target ulcer present for a minimum of 4 weeks, with post-debridement area of approximately 5-20 cm².
A subject known to have a life expectancy of less than 6 months.
If the target ulcer is infected or if there is cellulitis in the surrounding skin.
Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence; Wagner Grade ≥3.
A subject that has an infection in the target ulcer that requires systemic antibiotic therapy.
Parallel
High Purity Type-I Collagen-Based Skin Substitute and SOC
DeviceArm A - The SOC in this study is wound care covering with High Purity Type-I Collagen-Based Skin Substitute (Helicoll®) applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.
Acellular Intact Fish Skin Matrix and SOC
DeviceArm B - The SOC in this study is wound care covering with Acellular Intact Fish Skin Matrix (Kerecis Omega3 Wound®) applied weekly or as needed followed by a padded 3-layer dressing comprised of first layer - non-adherent and porous paraffin gauze, second layer - absorbent gauze pads \& third layer - soft roll and compressive wrap (crepe bandage). For participants enrolled in the optional histopathological sub-study, a 2-mm punch biopsy will be obtained from the wound edge at baseline and on Day 5 under local anesthesia. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, and sectioned at 4 μm for histological and immunohistochemical analysis.
Proportion of Participants Achieving Confirmed Complete Wound Closure
Complete wound closure is defined as 100% epithelialization of the target ulcer with no drainage and no clinically evident open area requiring dressing, confirmed by a blinded central adjudicator at a follow-up visit approximately 7 days after initial clinical closure is observed.
Percentage Wound Area Reduction Over Time
Percentage reduction in wound area from baseline, measured by standardized digital photography and central digital planimetry.
Proportion Achieving ≥50%, ≥75%, and ≥90% Wound-Area Reduction
Proportion of participants achieving each threshold of wound-area reduction relative to baseline.
Time to Confirmed Complete Wound Closure
Time from randomization to confirmed complete closure of the target ulcer, analyzed by Kaplan-Meier methods.
Mean Number of Study-Product Applications
Average number of applications of HPTC or AFSM required to achieve wound closure or study completion.
Tissue Advanced Glycation End-Product Accumulation (CML)
Quantification of Nε-(carboxymethyl)lysine (CML), a marker of tissue advanced glycation end-product accumulation relevant to impaired diabetic wound healing, in wound-edge biopsy specimens by ELISA (preferred) or immunohistochemistry with anti-CML antibody. Analysis Population Description: Histopathological sub-study subset only (approximately 30-40 participants, balanced between arms, at selected centres) - not assessed in the full 120-participant population.
Quantitative Collagen Organization and Maturation
Collagen density, fibre alignment, fibre orientation, and degree of organization in wound-edge biopsy specimens, assessed by Masson's Trichrome or Picrosirius Red staining with polarized light microscopy and quantified using digital image analysis software (ImageJ or QuPath). Analysis Population Description: Histopathological sub-study subset only.
Microvessel Density and Vascular Maturation
Angiogenesis assessed by CD31 immunohistochemistry (endothelial cell count, microvessel density expressed as vessels per high-power field, and CD31-positive area percentage), and vascular maturation assessed by α-smooth muscle actin (α-SMA) immunohistochemistry (mature/stabilized vessel count and activated myofibroblast density). Analysis Population Description: Histopathological sub-study subset only.
General Histopathological Wound Response (H&E)
Hematoxylin and eosin-stained wound-edge biopsy specimens assessed for inflammatory cell infiltrate, necrosis, epithelial migration, granulation tissue formation, and overall tissue architecture. Analysis Population Description: Histopathological sub-study subset only.
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Adichunchanagiri Institute of Medical Sciences, B G Nagara
Lead sponsor
Mysore Medical College and Research Institute, Mysurur
Collaborator
National Institute of Burn & Plastic Surgery, Dhaka
Collaborator
EKAGRA Health, Dhaka
Collaborator
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