Pressure SoreNCT06853210

Treatment of Pressure Ulcers Using Biological Skin Substitutes

A study testing Type-I Collagen-based Skin Substitute and SOC and Human Amnion/Chorion Membrane and SOC in people with Pressure Sore, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Pressure Sore
What is being tested?: Type-I Collagen-based Skin Substitute and SOC and Human Amnion/Chorion Membrane and SOC
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteIndia
Study dates: 1 Mar 2025to 25 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%)

Trial locations and contacts

1 site in 1 country.

India1 site

Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448

Other trials in India

About this study

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

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)

Read the 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.

Conditions: Pressure Sore
Being tested: Type-I Collagen-based Skin Substitute and SOC, Human Amnion/Chorion Membrane and SOC
Keywords: Pressure Sore, High Purity Type I Collagen, Helicoll, Biological Skin Substitute, Dehydrated Human Amnion/Chorion Membrane
Medical subject headings: Pressure Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06853210
Study group	Role	What they receive
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 Receives: 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 Receives: Device: Human Amnion/Chorion Membrane and SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Wound Area
Percent Change in Wound Area from week 1 through week 7 measured manually with digital photography
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline (Day 0), Day 5

Secondary outcomes (5)

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
Measured: 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
Measured: 6 weeks
Mean Number of Repeated Application
Mean number of reapplications of the HPTC \& dHACM used to obtain wound closure over 6 Weeks
Measured: 6 weeks
Adverse Events
Adverse events (e.g., infection, allergic reactions)
Measured: 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"
Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202525 Jul 2025

First posted28 Feb 2025
Study start1 Mar 2025
Primary completion10 Jul 2025
Study completion25 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Pressure SoreStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06853210
Sponsor's protocol ID: AIMS/IEC/012/2025
Status last verified: Aug 2025
First submitted: 25 Feb 2025
Last updated: 29 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 24050454
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.
PubMed 37711741
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.
PubMed 31067170
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.
PubMed 39649230

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Chronic Ulcers
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The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
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All Pressure Sore trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Pressure Ulcers Using Biological Skin Substitutes: A Comparison of High Purity Type-I Collagen and Amnion/Chorion Membranes
ClinicalTrials.gov ID: NCT06853210
Acronym / sponsor ID: AIMS/IEC/012/2025
Conditions: Pressure Sore
Keywords: Pressure Sore, High Purity Type I Collagen, Helicoll, Biological Skin Substitute, Dehydrated Human Amnion/Chorion Membrane
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
Study start: 1 Mar 2025 (actual)
Primary completion: 10 Jul 2025 (actual)
Study completion: 25 Jul 2025 (actual)
First posted: 28 Feb 2025 (actual)
Results: Posted 29 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High Purity Type-I Collagen-based Skin Substitute	Active comparator	Device: Type-I Collagen-based Skin Substitute and SOCThe 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
Dehydrated Human Amnion/Chorion Membrane	Active comparator	Device: Human Amnion/Chorion Membrane and SOCThe SOC in this study is wound care covering with Dehydrated Human Amnion/Chorion Membrane followed by a padded 3-layer dressing

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Type-I Collagen-based Skin Substitute and SOCThe 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	Device	High Purity Type-I Collagen-based Skin Substitute
Human Amnion/Chorion Membrane and SOCThe 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	Device	Dehydrated Human Amnion/Chorion Membrane

Primary outcome

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
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) 1. Mild infiltration (5-10 vessels/hpf) 2. Moderate infiltration (11-20 vessels/hpf) 3. Abundant infiltration (>20 vessels/hpf) (0-worse; 3-better)
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 1. Minimal migration (<25% wound coverage) 2. Moderate migration (25-75% coverage) 3. Extensive migration (>75% coverage) (0-worse; 3-better)
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 1. Moderate cellularity, minimal matrix production 2. High cellularity, active-matrix synthesis 3. Very high activity with extensive matrix deposition (0-worse; 3-better)
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 1. Mild chronic inflammation 2. Moderate mixed inflammation 3. Severe acute inflammation (0-better; 3-worse)
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
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 1. Loose, immature collagen 2. Moderate organized collagen 3. Dense, mature collagen architecture (0-worse; 3-better)

5 secondary outcomes

Complete Wound Closure Rates
Time frame: 7 weeks
Wound Size Progression Over Time
Time frame: 6 weeks
Mean Number of Repeated Application
Time frame: 6 weeks
Adverse Events
Time frame: 6 weeks
Patient Treatment Satisfaction
Time frame: 7 weeks

Results and safety

Results posted to the registry on 29 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Purity Type-I Collagen-based Skin Substitute	40	40
Dehydrated Human Amnion/Chorion Membrane	40	40

Primary outcome: Percent Change in Wound Area

Time frame: 7 weeks. Mean (Standard Deviation). Unit: percentage change

Measure	High Purity Type-I Collagen-based Skin Substitute n = 40	Dehydrated Human Amnion/Chorion Membrane n = 40
Value	-78.5 (18.2)	-65.1 (9.8)

Primary outcome: Histopathological Parameters - Vascular Infiltration

Time frame: Baseline (Day 0), Day 5. Count of participants. Unit: Participants

Measure	High Purity Type-I Collagen-based Skin Substitute n = 40	Dehydrated Human Amnion/Chorion Membrane n = 40
Day 0 / Baseline: Grade 0	11	17
Day 0 / Baseline: Grade 1	15	14
Day 0 / Baseline: Grade 2	8	6
Day 0 / Baseline: Grade 3	6	3
Day 5 Post Application: Grade 0	0	4
Day 5 Post Application: Grade 1	2	13
Day 5 Post Application: Grade 2	7	15
Day 5 Post Application: Grade 3	31	8

Primary outcome: Histopathological Parameters - Neo-epithelialization

Time frame: Baseline (Day 0), Day 5. Count of participants. Unit: Participants

Measure	High Purity Type-I Collagen-based Skin Substitute n = 40	Dehydrated Human Amnion/Chorion Membrane n = 40
Day 0 / Baseline: Grade 0	18	24
Day 0 / Baseline: Grade 1	12	10
Day 0 / Baseline: Grade 2	7	4
Day 0 / Baseline: Grade 3	3	2
Day 5 of Post Application: Grade 0	0	6
Day 5 of Post Application: Grade 1	4	15
Day 5 of Post Application: Grade 2	8	10
Day 5 of Post Application: Grade 3	28	9

Primary outcome: Histopathological Parameters - Fibroblast Activity

Time frame: Baseline (Day 0), Day 5. Count of participants. Unit: Participants

Measure	High Purity Type-I Collagen-based Skin Substitute n = 40	Dehydrated Human Amnion/Chorion Membrane n = 40
Day 0 / Baseline: Grade 0	7	12
Day 0 / Baseline: Grade 1	17	16
Day 0 / Baseline: Grade 2	13	10
Day 0 / Baseline: Grade 3	3	2
Day 5 Post Application: Grade 0	0	3
Day 5 Post Application: Grade 1	2	15
Day 5 Post Application: Grade 2	5	15
Day 5 Post Application: Grade 3	33	7

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 7 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Purity Type-I Collagen-based Skin Substitute	0 of 40 (0%)	2 of 40 (5%)	0 of 40
Dehydrated Human Amnion/Chorion Membrane	0 of 40 (0%)	6 of 40 (15%)	0 of 40

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24050454Bergstrom 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.
Background: PubMed 37711741Vecin 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.
Background: PubMed 31067170Berhane 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.
Background: PubMed 39649230Narayan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prema Dhanraj, MS, MCh study chair

Rajarajeshwari Medical College and Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Wound Area (time frame: 7 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06853210, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.