Treatment of Pressure Ulcers Using Biological Skin Substitutes

Adichunchanagiri Institute of Medical Sciences, B G Nagara

Status: Completed

Conditions: Pressure Sore

Treatments: Device: Type-I Collagen-based Skin Substitute and SOC; Device: Human Amnion/Chorion Membrane and SOC

Study type: Interventional

Funder types: Other

Identifiers

NCT06853210

AIMS/IEC/012/2025

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

High Purity Type-I Collagen-based Skin Substitute

Active Comparator group

Description:

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

Treatment:

Device: Type-I Collagen-based Skin Substitute and SOC

Dehydrated Human Amnion/Chorion Membrane

Active Comparator group

Description:

The SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing

Treatment:

Device: Human Amnion/Chorion Membrane and SOC