Treatment of Pressure Ulcers Using Biological Skin Substitutes

Adichunchanagiri Institute of Medical Sciences, B G Nagara80 enrolled

Overview

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM)

Pressure ulcers, also known as decubitus ulcers or bedsores, are localized injuries to the skin and underlying tissue resulting from prolonged pressure. They are prevalent in individuals with limited mobility, such as the elderly and those with spinal cord injuries, particularly in long-term care settings. Effective management of pressure ulcers is crucial to prevent complications and improve patient outcomes, includes pressure relief, wound care, and advanced therapies such as bioengineered skin substitutes. Management of pressure sores is crucial due to their association with increased morbidity, healthcare costs, and reduced quality of life. This study aims to evaluate the efficacy of two treatment modalities: Type-I Collagen-based Skin Substitute (HPTC) vs. Dehydrated Human Amnion/Chorion Membrane (dHCAM) in promoting the healing of pressure ulcers. While both products are used in wound management, direct comparative studies evaluating their efficacy in treating pressure ulcers are limited.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pressure Sore

Interventions

Type-I Collagen-based Skin Substitute and SOCDEVICE

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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

Human Amnion/Chorion Membrane and SOCDEVICE

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, second layer - absorbent 4x4 gauze pads \& third layer - soft roll and compressive wrap

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects must be at least 18 years of age or older 2. Presence of a Stage II or Stage III pressure ulcer, as defined by the National Pressure Ulcer Advisory Panel 3. Ulcer size between 5 cm² and 25 cm² 4. Ulcer duration of at least 4 weeks prior to enrollment 5. The subject must agree to attend the twice-weekly/weekly study visits required by the protocol 6. The subject must be willing and able to participate in the informed consent process 7. Adequate blood supply to the affected area, confirmed by clinical assessment Exclusion Criteria: 1. A subject known to have a life expectancy of \<6 months 2. Presence of infection in the ulcer requiring systemic antibiotics. 3. Known allergy to components of HPTC or dHCAM. 4. Participation in another wound care study within the last 30 days. 5. A subject with autoimmune or connective tissue disorders. 6. Women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding. 7. History of autoimmune disease, immunosuppressive therapy, malignancy, or uncontrolled diabetes (HbA1c \>10%)

Locations (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, India

Outcomes

Primary Outcomes

Percent Change in Wound Area

Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography

Time frame: 7 weeks

Histopathological Parameters - Vascular Infiltration

A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with Hematoxylin and Eosin (H\&E) for general morphology. Vascular Infiltration: Assessed by counting new blood vessels per High Power Field (hpf) (0-3 scale) 0: Minimal vascular ingrowth (\<5 vessels/hpf) 1. Mild infiltration (5-10 vessels/hpf) 2. Moderate infiltration (11-20 vessels/hpf) 3. Abundant infiltration (\>20 vessels/hpf) (0-worse; 3-better)

Time frame: Baseline (Day 0), Day 5

Histopathological Parameters - Neo-epithelialization

A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: Hematoxylin and Eosin (H\&E) for general morphology. Neo-epithelialization: Measured as epithelial migration distance from wound edge (0-3 scale) 0: No epithelial migration 1. Minimal migration (\<25% wound coverage) 2. Moderate migration (25-75% coverage) 3. Extensive migration (\>75% coverage) (0-worse; 3-better)

Time frame: Baseline (Day 0), Day 5

Histopathological Parameters - Fibroblast Activity

A 2mm punch biopsy was obtained from the wound edge extending into the wound bed under local anaesthesia. Serial sections of 4μm thickness were prepared and stained with: α-SMA immunohistochemistry for fibroblast activity. Fibroblast Activity: Quantified by counting α-SMA positive fibroblasts per HPF and assessment of fibroblast morphology (0-3 scale) 0: Sparse, inactive fibroblasts 1. Moderate cellularity, minimal matrix production 2. High cellularity, active-matrix synthesis 3. Very high activity with extensive matrix deposition (0-worse; 3-better)

Time frame: Baseline (Day 0), Day 5

Histopathological Parameters - Inflammatory Response

Data from ClinicalTrials.gov

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Secondary Outcomes

Complete Wound Closure Rates

Percentage of subjects to obtain complete closure, defined as 100% epithelialization with no drainage, of the target ulcer was determined by the proportion of subjects that obtain complete closure over the 6-week treatment period and additional 1 week follow up

Time frame: 7 weeks

Wound Size Progression Over Time

Mean wound sizes at each time point for both treatment groups assessing change in wound size throughout the study period. Assessed from baseline, through day 5, 14th day, 21 st day, 28th, 35th and 42nd days of HPTC or dHACM application

Time frame: 6 weeks

Mean Number of Repeated Application

Mean number of reapplications of the HPTC \& dHACM used to obtain wound closure over 6 Weeks

Time frame: 6 weeks

Adverse Events

Adverse events (e.g., infection, allergic reactions)

Time frame: 6 weeks

Patient Treatment Satisfaction

Patient treatment satisfaction will be assessed by using a validated 5-point Likert scale questionnaire administered at 7 weeks post-treatment initiation. The questionnaire evaluated overall treatment satisfaction, comfort during application, perceived effectiveness, and willingness to recommend the treatment to others, measured with score range from 1 to 5, wherein 1="Extremally Unsatisfied" to 5="Extremally Satisfied"

Time frame: 7 weeks