Clinical trial NCT06853210: Treatment of Pressure Ulcers Using Biological Skin Substitutes
Official title: Treatment of Pressure Ulcers Using Biological Skin Substitutes: A Comparison of High Purity Type-I Collagen and Amnion/Chorion Membranes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pressure Sore
Keywords: Pressure Sore
High Purity Type I Collagen
Helicoll
Biological Skin Substitute
Dehydrated Human Amnion/Chorion Membrane
Lead sponsor: Adichunchanagiri Institute of Medical Sciences, B G Nagara
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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%)

Primary outcomes:
measure: Percentage wound area reduction
timeFrame: 4 weeks
Secondary outcomes:
measure: Time to achieve complete wound closure
timeFrame: 4 weeks
measure: Infiltration of vascularity in the ulcer bed
timeFrame: 6 days
measure: Mean number of repeated application
timeFrame: 4 weeks
measure: Incidence of adverse events
timeFrame: 4 weeks
measure: Patient treatment satisfaction
timeFrame: 4 weeks including 1-week follow-up
Other outcomes:
Locations:
city: Mandya
country: India
facility: Adichunchanagiri Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: Rajarajeshwari Medical College and Hospital
name: Prema Dhanraj, MS, MCh
role: STUDY_CHAIR
References:
citation: Bergstrom N, Horn SD, Rapp MP, Stern A, Barrett R, Watkiss M. Turning for Ulcer ReductioN: a multisite randomized clinical trial in nursing homes. J Am Geriatr Soc. 2013 Oct;61(10):1705-13. doi: 10.1111/jgs.12440. Epub 2013 Sep 19.
citation: Vecin NM, Kirsner RS. Skin substitutes as treatment for chronic wounds: current and future directions. Front Med (Lausanne). 2023 Aug 29;10:1154567. doi: 10.3389/fmed.2023.1154567. eCollection 2023.
citation: Berhane CC, Brantley K, Williams S, Sutton E, Kappy C. An evaluation of dehydrated human amnion/chorion membrane allografts for pressure ulcer treatment: a case series. J Wound Care. 2019 May 1;28(Sup5):S4-S10. doi: 10.12968/jowc.2019.28.Sup5.S4.
citation: Narayan N, Gowda S, Shivannaiah C. A Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers. Cureus. 2024 Dec 5;16(12):e75182. doi: 10.7759/cureus.75182. eCollection 2024 Dec.