Treatment of Pressure Ulcers Using Biological Skin Substitutes

NCT06853210 | Completed Results FDA Device

• 1 other identifier: AIMS/IEC/012/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Pressure Sore

Keywords

Pressure Sore; High Purity Type I Collagen; Helicoll; Biological Skin Substitute; Dehydrated Human Amnion/Chorion Membrane

Outcome Measures

Primary Outcomes (7)

• Percent Change in Wound Area

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

  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)

  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)

  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)

  Baseline (Day 0), Day 5

• Histopathological Parameters - Inflammatory Response

  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 1. Mild chronic inflammation 2. Moderate mixed inflammation 3. Severe acute inflammation (0-better; 3-worse)

  Baseline (Day 0), Day 5

• Histopathological Parameters - Capillary Density

  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

  Baseline (Day 0), Day 5

• Histopathological Parameters - Collagen Deposition

  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 1. Loose, immature collagen 2. Moderate organized collagen 3. Dense, mature collagen architecture (0-worse; 3-better)

  Baseline (Day 0), Day 5

Secondary Outcomes (5)

• Complete Wound Closure Rates

  7 weeks

• Wound Size Progression Over Time

  6 weeks

• Mean Number of Repeated Application

  6 weeks

• Adverse Events

  6 weeks

• Patient Treatment Satisfaction

  7 weeks

Other Outcomes (1)

• Change in Quality of Life

  7 weeks

Study Arms (2)

High Purity Type-I Collagen-based Skin Substitute

ACTIVE COMPARATOR

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

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

Dehydrated Human Amnion/Chorion Membrane

ACTIVE COMPARATOR

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

Device: Human Amnion/Chorion Membrane and SOC

Interventions

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

High Purity Type-I Collagen-based Skin Substitute

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

Dehydrated Human Amnion/Chorion Membrane

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Adichunchanagiri Institute of Medical Sciences, B G Nagara: lead

Study Sites (1)

Adichunchanagiri Institute of Medical Sciences

Mandya, Karnataka, 571448, India

Location

Related Publications (4)

• 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.

  PMID: 24050454 BACKGROUND

• 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.

  PMID: 37711741 BACKGROUND

• 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.

  PMID: 31067170 BACKGROUND

• 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.

  PMID: 39649230 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Single-centre design may limit generalizability to other healthcare settings and populations. Relatively short follow-up period (7 weeks), while sufficient for assessing acute healing outcomes, may not capture long-term outcomes, recurrence rates or durability of treatment effects. The Study was not completely blinded due to the nature of the interventions Study included a specific range of wound sizes and may not be generalizable to very large wounds.

Results Point of Contact

• Title: Dr Naveen N
• Organization: Adichunchanagiri Institute of Medical Sciences

naveen_uno1@yahoo.co.in

+91-9980023372

Study Officials

• Prema Dhanraj, MS, MCh

  Rajarajeshwari Medical College and Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and HOD

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: March 1, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 25, 2025
• Last Updated: August 29, 2025
• Results First Posted: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)