Full Thickness Skin DefectsNCT06873867
Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
A study testing High Purity Type-I Collagen based Skin Substitute and Negative Pressure Wound Therapy in people with Full Thickness Skin Defects and Ulcer, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.
Trial summary
Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Full Thickness Skin Defects, Ulcer
- What is being tested?
- High Purity Type-I Collagen based Skin Substitute and Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteIndia
- Study dates
- 15 Mar 2025to 30 Sep 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 full-thickness wound of at least 4 cm² and no more than 100 cm².
- Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
- Adequate vascular supply to the affected area
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- 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.
Who cannot join
- A subject known to have a life expectancy of <6 months
- Wounds with active infection / osteomyelitis requiring systemic antibiotics.
- Presence of malignancy in the wound bed.
- Patients with uncontrolled diabetes (HbA1c > 9%).
- Use of immunosuppressive therapy or systemic corticosteroids.
- Use of other advanced wound care products within the past 30 days
Show all 12Show fewer
- Known allergy to fish products or components of HPTC.
- Pregnant or breastfeeding women.
- Presence of osteomyelitis or exposed bone, probes to bone or joint capsule on investigator's exam or radiographic evidence.
- A subject receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy.
- A subject with autoimmune or connective tissue disorders.
- A subject who participated in a clinical trial involving treatment with an investigational product within the previous 30 days.
Trial locations and contacts
1 site in 1 country.
India1 site
Adichunchanagiri Institute of Medical Sciences
Mandya, Karnataka, 571448
About this study
Official title: A Comparative Analysis in Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Read the detailed description
Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
- Conditions
- Full Thickness Skin Defects, Ulcer
- Being tested
- High Purity Type-I Collagen based Skin Substitute, Negative Pressure Wound Therapy
- Keywords
- Full Thickness Skin Defects, Ulcer, Negative Pressure Wound Therapy, High Purity Type 1 Collagen, Helicoll
- Medical subject headings
- Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Purity Type-I Collagen based Skin SubstituteDevice
In this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed
Negative Pressure Wound TherapyDevice
In this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed
| Study group | Role | What they receive |
|---|---|---|
| High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy | Active comparator | In this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. Receives: Device: High Purity Type-I Collagen based Skin Substitute; Device: Negative Pressure Wound Therapy |
| Negative Pressure Wound Therapy | Active comparator | In this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. Receives: Device: Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Wound Area
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
Measured: 7 weeks
Secondary outcomes (10)
Histopathological Analysis on Day 5 of Study
Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for:
vascular infiltration (0-3 scale) - higher score means better, neo-epithelialization (0-3 scale) - higher score means better, fibroblast activity (0-3 scale) - higher score means better, inflammatory response (0-3 scale) - lower score means better and collagen deposition (0-3 scale) - higher score means better
Measured: 5 days
Histopathological Analysis on Day 5 of Study - Capillary Density
Histopathological assessment will be done using biopsy on Day 0 of application to be compared with Day 5 after application of Type-I Collagen-based Skin Substitute or Human Amnion/Chorion Membrane. Histopathology assessed at day 0 and day 5, day 5 reported. Subsequently histopathology of biopsy will be done to look for capillary density (vessels per mm²) - higher count means better,
Measured: 5 days
Time to Achieve Complete Wound Closure
The time to achieve complete wound closure of the target ulcer by the end of 7 weeks
Measured: 7 weeks
Percentage of Participants to Obtain Complete Wound Closure
The percentage of participants that obtain complete wound closure over the 7 weeks (6 weeks treatment period plus 1 week follow up)
Measured: 7 weeks
Percentage of Participants Achieving ≥50% Wound Healing
Measurement of percentage of participants achieving ≥50% wound healing (epithelialization) assessed at follow up
Measured: 7 weeks
Mean Number of Application
Mean number of rapplications of the NPWT+HPTC \& NPWT alone used to obtain wound closure
Measured: 6 weeks
Number of Adverse Events
Number of adverse events related to the intervention (e.g., infection, allergic reactions, NPWT seal issues)
Measured: 6 weeks
Pain Score on Visual Analog Scale
Pain measured by a Visual Analog Scale with score range from 0 to 10, wherein 0="no pain" to 10="severe pain"
Measured: 7 weeks
Healed Wound Appearance Assessment Using Vancouver Scar Scale
The resultant new skin is assessed and documented at each visit using the Vancouver Scar Scale, up to 7 weeks, week 7 visit reported, assessing vascularity, pigmentation, pliability and height/thickness with total score ranging from 0 to 13 (lesser the score better the scar)
Measured: 7 weeks
Quality of Life Assessment
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument is a standardized patient-reported outcome measure assessing overall health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Scoring and Ranges:
- EQ-5D-5L Index Score - Derived from the five dimensions with five levels each (1 = no problems; 5 = extreme problems). The index score range varies by population value set; for most countries the possible scoring range is approximately -0.594 to 1.000. Higher scores indicate better health status (1.000 = full health).
- EQ Visual Analogue Scale (EQ-VAS) - A self-rated health scale from 0 to 100, where, 0 = the worst health you can imagine, 100 = the best health you can imagine. Higher values reflect better outcomes.
Interpretation:
Higher scores on both the EQ-5D-5L Index and EQ-VAS represent improved quality of life and a better treatment outcome.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start15 Mar 2025
- Primary completion30 Aug 2025
- Study completion30 Sep 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 (5)Papers the sponsor has linked to this study.
- Other trials for Full Thickness Skin DefectsStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Naveen Narayan MS, MCh (Plastic Surgery), Adichunchanagiri Institute of Medical Sciences, B G Nagara
- Investigators
- Prema Dhanraj, MS, MCh, Study chair, Rajarajeshwari Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873867
- Sponsor's protocol ID
- AIMS/IEC/013/2025
- Status last verified
- Nov 2025
- First submitted
- 3 Mar 2025
- Last updated
- 21 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
PubMed 17425550Lee SK, An YS, Choy WS. Management of Hardware-Exposed Soft Tissue Defects Using Dermal Substitutes and Negative Pressure Wound Therapy. Ann Plast Surg. 2023 Mar 1;90(3):242-247. doi: 10.1097/SAP.0000000000003440.
PubMed 36796046Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.
PubMed 33344649Dhanraj P, Naveen N, Babu KR, Mahesh MS Hanumanthaiah KS. Healicoll: An Alternate to Flap Cover for Bare Bones and Tendons. Acta Medica International, 2016; 3(1): 146-150
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis in Treatment of Full-Thickness Wounds: NPWT Combined With Type-I Collagen Based Advanced Skin Substitute Versus NPWT Alone
- ClinicalTrials.gov ID
- NCT06873867
- Acronym / sponsor ID
- AIMS/IEC/013/2025
- Conditions
- Full Thickness Skin Defects, Ulcer
- Keywords
- Full Thickness Skin Defects, Ulcer, Negative Pressure Wound Therapy, High Purity Type 1 Collagen, Helicoll
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Adichunchanagiri Institute of Medical Sciences, B G NagaraUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 13 Mar 2025 (actual)
- Results
- Posted 21 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
Detailed description
Full-thickness wounds, extending through the dermis and affecting underlying tissues, present significant clinical challenges due to their complexity and prolonged healing times. Traditional treatments include surgical debridement, dressings, and advanced therapies like Negative Pressure Wound Therapy (NPWT). Widely used NPWT has been shown to promote wound healing by applying sub-atmospheric pressure, reducing oedema, and enhancing granulation tissue formation thus enhancing wound healing. However, its efficacy can vary based on wound characteristics and patient factors. High Purity Type-I Collagen (HPTC) based advanced skin substitute has emerged as a potential alternative for wound management, accelerating wound healing through extracellular matrix support. Studies suggest that HPTC promote cellular proliferation and angiogenesis, essential for tissue regeneration. Given the distinct mechanisms of action of NPWT and HPTC, a comparative evaluation is warranted to determine their relative efficacy in treating full-thickness wounds. This study aims to compare the efficacy of NPWT combined with HPTC versus NPWT alone in the treatment of full-thickness wounds.
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 with Negative Pressure Wound Therapy | Active comparator | Device: High Purity Type-I Collagen based Skin Substitute, Device: Negative Pressure Wound TherapyIn this study arm, wound is covered with High Purity Type-I Collagen (HPTC) based Skin Substitute applied followed by non adherent porous dressing followed by Negative Pressure Wound Therapy application set at 125mm of Hg pressure for 7 days. Procedure will be redone in case of need. |
| Negative Pressure Wound Therapy | Active comparator | Device: Negative Pressure Wound TherapyIn this study arm, wound is covered with non adherent porous dressing followed by Negative Pressure Wound Therapy application alone. Pressure is set at 125mm of Hg for 7 days. Procedure will be redone in case of need. |
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 full-thickness wound of at least 4 cm² and no more than 100 cm².
- Wound duration of at least 4 weeks but not exceeding 6 months of standard of care prior to the initial screening visit.
- Adequate vascular supply to the affected area
- If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
Key exclusion criteria (12 listed)
- A subject known to have a life expectancy of <6 months
- Wounds with active infection / osteomyelitis requiring systemic antibiotics.
- Presence of malignancy in the wound bed.
- Patients with uncontrolled diabetes (HbA1c > 9%).
- Use of immunosuppressive therapy or systemic corticosteroids.
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 |
|---|---|---|
| High Purity Type-I Collagen based Skin SubstituteIn this wound care is covering with High Purity Type-I Collagen based Skin Substitute followed by a layer of non-adherent and porous dressing. After 5-7 days, wound examined and procedure is repeated as needed | Device | High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy |
| Negative Pressure Wound TherapyIn this wound care is by application of Negative Pressure Wound Therapy using a standard polyurethane foam. The NPWT will be removed after 5-7 days, wound examined and procedure is repeated as needed | Device | High Purity Type-I Collagen based Skin Substitute with Negative Pressure Wound Therapy, Negative Pressure Wound Therapy |
Primary outcome
Percentage Change in Wound Area
Time frame: 7 weeks
Percentage change in wound area from week 1 through week 7 measured manually with digital photography
10 secondary outcomes
Histopathological Analysis on Day 5 of Study
Time frame: 5 days
Histopathological Analysis on Day 5 of Study - Capillary Density
Time frame: 5 days
Time to Achieve Complete Wound Closure
Time frame: 7 weeks
Percentage of Participants to Obtain Complete Wound Closure
Time frame: 7 weeks
Percentage of Participants Achieving ≥50% Wound Healing
Time frame: 7 weeks
Mean Number of Application
Time frame: 6 weeks
Number of Adverse Events
Time frame: 6 weeks
Pain Score on Visual Analog Scale
Time frame: 7 weeks
Healed Wound Appearance Assessment Using Vancouver Scar Scale
Time frame: 7 weeks
Quality of Life Assessment
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17425550Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.
- Background: PubMed 36796046Lee SK, An YS, Choy WS. Management of Hardware-Exposed Soft Tissue Defects Using Dermal Substitutes and Negative Pressure Wound Therapy. Ann Plast Surg. 2023 Mar 1;90(3):242-247. doi: 10.1097/SAP.0000000000003440.
- Background: PubMed 33344649Zhang L, Weng T, Wu P, Li Q, Han C, Wang X. The Combined Use of Negative-Pressure Wound Therapy and Dermal Substitutes for Tissue Repair and Regeneration. Biomed Res Int. 2020 Dec 4;2020:8824737. doi: 10.1155/2020/8824737. eCollection 2020.
- BackgroundDhanraj P, Naveen N, Babu KR, Mahesh MS Hanumanthaiah KS. Healicoll: An Alternate to Flap Cover for Bare Bones and Tendons. Acta Medica International, 2016; 3(1): 146-150
- 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?
A study testing High Purity Type-I Collagen based Skin Substitute and Negative Pressure Wound Therapy in people with Full Thickness Skin Defects and Ulcer, run by Adichunchanagiri Institute of Medical Sciences, B G Nagara at 1 site in India.
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 12 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 21 Nov 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 21 Nov 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?
Percentage Change in Wound Area (time frame: 7 weeks). 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 NCT06873867, which also lists 5 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 21 Nov 2025.