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Completed

NCT Number: NCT06853210

Treatment of Pressure Ulcers Using Biological Skin Substitutes

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)

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Key information

Conditions

Pressure Sore Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be at least 18 years of age or older
  • Presence of a Stage II or Stage III pressure ulcer, as defined by the National Pressure Ulcer Advisory Panel
  • Ulcer size between 5 cm² and 25 cm²
  • Ulcer duration of at least 4 weeks prior to enrollment
  • 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
  • Adequate blood supply to the affected area, confirmed by clinical assessment

Exclusion criteria

  • A subject known to have a life expectancy of <6 months
  • Presence of infection in the ulcer requiring systemic antibiotics.
  • Known allergy to components of HPTC or dHCAM.
  • Participation in another wound care study within the last 30 days.
  • A subject with autoimmune or connective tissue disorders.
  • Women who are pregnant or considering becoming pregnant within the next 6 months and those who are breast feeding.
  • History of autoimmune disease, immunosuppressive therapy, malignancy, or uncontrolled diabetes (HbA1c >10%)

Treatment and study plan

Type-I Collagen-based Skin Substitute and SOC

Device

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 SOC

Device

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

Primary outcomes

  1. Percent Change in Wound Area

    Time frame: 7 weeks

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

  2. Histopathological Parameters - Vascular Infiltration

    Time frame: Baseline (Day 0), Day 5

    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)

    • Mild infiltration (5-10 vessels/hpf)
    • Moderate infiltration (11-20 vessels/hpf)
    • Abundant infiltration (>20 vessels/hpf) (0-worse; 3-better)

  3. Histopathological Parameters - Neo-epithelialization

    Time frame: Baseline (Day 0), Day 5

    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

    • Minimal migration (<25% wound coverage)
    • Moderate migration (25-75% coverage)
    • Extensive migration (>75% coverage) (0-worse; 3-better)

  4. Histopathological Parameters - Fibroblast Activity

    Time frame: Baseline (Day 0), Day 5

    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

    • Moderate cellularity, minimal matrix production
    • High cellularity, active-matrix synthesis
    • Very high activity with extensive matrix deposition (0-worse; 3-better)

  5. Histopathological Parameters - Inflammatory Response

    Time frame: Baseline (Day 0), Day 5

    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 Inflammatory Response: Graded semi-quantitatively (0-3 scale) 0: Minimal inflammatory infiltrate

    • Mild chronic inflammation
    • Moderate mixed inflammation
    • Severe acute inflammation

    (0-better; 3-worse)

  6. Histopathological Parameters - Capillary Density

    Time frame: Baseline (Day 0), Day 5

    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: CD31 immunohistochemistry for capillary density evaluation Capillary Density: Evaluated using CD31 staining, counted as vessels per mm² of tissue

    More the vessels per square centimeters better

  7. Histopathological Parameters - Collagen Deposition

    Time frame: Baseline (Day 0), Day 5

    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: Masson's Trichrome for collagen assessment Collagen Deposition: Assessed using Masson's Trichrome staining (0-3 scale) 0: Minimal collagen matrix

    • Loose, immature collagen
    • Moderate organized collagen
    • Dense, mature collagen architecture

    (0-worse; 3-better)

Secondary outcomes

  1. Complete Wound Closure Rates

    Time frame: 7 weeks

    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

  2. Wound Size Progression Over Time

    Time frame: 6 weeks

    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

  3. Mean Number of Repeated Application

    Time frame: 6 weeks

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

  4. Adverse Events

    Time frame: 6 weeks

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

  5. Patient Treatment Satisfaction

    Time frame: 7 weeks

    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"

Other outcomes

  1. Change in Quality of Life

    Time frame: 7 weeks

    Change in quality of life assessed using the Wound-QoL questionnaire measured as 'not at all', 'a little', 'moderately', 'quite a lot' and 'very much' for 17 questions and total number of patients who reported improvement in Quality of Life was measured

Sponsors and collaborators

Lead sponsor

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Other

Registry information

Official study title

Treatment of Pressure Ulcers Using Biological Skin Substitutes: A Comparison of High Purity Type-I Collagen and Amnion/Chorion Membranes

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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