Non-healing WoundAMNIODERM+NCT06442865
AMNIODERM+ Medical Device Clinical Study
An observational study of Non-healing Wound and Diabetic Foot, run by BioHealing s.r.o. at 1 site in Slovakia.
Trial summary
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-healing Wound, Diabetic Foot
- What is being tested?
- AMNIODERM+
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSlovakia
- Study dates
- 16 Nov 2022to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Who may be able to join
- Males and females over 18 years of age
- Type 1 or Type 2 diabetes mellitus
- Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
- History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
- Size of a wound to be evaluated 2 to 16 cm2
- Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision
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- The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial
- The subject is able to understand the clinical trial information
- Signed informed consent form
- Data on previous wound care are available in the subject medical documentation
Who cannot join
- Necrotic wound requiring surgical treatment
- Pregnancy or breastfeeding
- Venous etiology of ulceration
- Burns or chemical burns
- Clinical manifestations of systemic infection
- Undermined wound edges
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- The wound involves deeper structures (bone, tendons, joints)
- Inadequately controlled diabetes mellitus with HbA1c > 12 % (DCCT) diabetes mellitus
- Renal insufficiency with eGF < 30ml/min/1.73m2
- Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP >10
- Topical treatment with any growth factor-based products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.
- Conditions
- Non-healing Wound, Diabetic Foot
- Being tested
- AMNIODERM+
- Keywords
- medical device, AMNIODERM+, non-healing wounds, DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMNIODERM+Device
A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties.
The product will be evaluated in the subjects not responding to SoC.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective data | Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Retrospective data will contain information about the subject's history and wound treatment by SoC. Receives: Device: AMNIODERM+ | |
| Prospective data | Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Prospective data will contain information about wound treatment by AMNIODERM+®. Receives: Device: AMNIODERM+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-healing wounds measuring
Analyses of primary and secondary endpoints: The error rate During data collection, a change was made to the CIP regarding complete wound closure (wound heal). Whether a wound was healed was determined by the opinion of the investigator and not by the size of the wound as measured by Imito® application. The error rate of the Imito® measuring application in determining the size of the wound was 10 %, i.e. based on that and clinical experience the threshold of 0.1 cm2 was determined. Wounds smaller than or equal to 0.1 cm2 were considered as complete closure. The investigator confirmed the wound closure in an accompanying comment in the eCRF.
Measured: 6 + 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start16 Nov 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-healing WoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioHealing s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442865
- Sponsor's protocol ID
- AD+29082022ZP
- Acronym
- AMNIODERM+
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freeze-dried Amniotic Membrane in the Treatment of Non-healing Wounds: a Single-arm, Retrospectivelyprospective Clinical Trial
- ClinicalTrials.gov ID
- NCT06442865
- Acronym / sponsor ID
- AMNIODERM+ / AD+29082022ZP
- Conditions
- Non-healing Wound, Diabetic Foot
- Keywords
- medical device, AMNIODERM+, non-healing wounds, DFU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BioHealing s.r.o.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is retrospectively-prospective clinical trial with medical device AMNIODERM+ intended for the non-healing wounds. Retrospective data will contain information about the subject's history and wound treatment by SoC. Prospective data will contain information about wound treatment by AMNIODERM+®.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective data | – | Device: AMNIODERM+Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion. Retrospective data will contain information about the subject's history and wound treatment by SoC. |
| Prospective data | – | Device: AMNIODERM+Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion. Prospective data will contain information about wound treatment by AMNIODERM+®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with a diabetic neuropathic or neuroischemic wounds, anywhere on the leg, ranging in size between 2 cm2 and 16 cm2, that has not healed at least 20% after the 6 weeks of the standard of care (SoC) with the known therapeutic history ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion.
Key inclusion criteria (10 listed)
- Males and females over 18 years of age
- Type 1 or Type 2 diabetes mellitus
- Presence of a diabetic neuropathic or neuroischemic wound, anywhere on the leg, that has not healed at least 20% after the 6 weeks of the standard of care (SoC)
- History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion
- Size of a wound to be evaluated 2 to 16 cm2
Key exclusion criteria (11 listed)
- Necrotic wound requiring surgical treatment
- Pregnancy or breastfeeding
- Venous etiology of ulceration
- Burns or chemical burns
- Clinical manifestations of systemic infection
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 |
|---|---|---|
| AMNIODERM+A common surgical approach in chronic wound treatment aims at the promotion of epithelization by a combination of debridement manipulations (removal of non-vital tissues) and infection/inflammation management using antibacterial wound dressings (antibiotics or silver covering). The advantages of biomaterials can be attributed to their unique mechanical, immunological, and regenerative properties. The product will be evaluated in the subjects not responding to SoC. | Device | Prospective data, Retrospective data |
Primary outcome
Non-healing wounds measuring
Time frame: 6 + 12 weeks
Analyses of primary and secondary endpoints: The error rate During data collection, a change was made to the CIP regarding complete wound closure (wound heal). Whether a wound was healed was determined by the opinion of the investigator and not by the size of the wound as measured by Imito® application. The error rate of the Imito® measuring application in determining the size of the wound was 10 %, i.e. based on that and clinical experience the threshold of 0.1 cm2 was determined. Wounds smaller than or equal to 0.1 cm2 were considered as complete closure. The investigator confirmed the wound closure in an accompanying comment in the eCRF.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-healing Wound and Diabetic Foot, run by BioHealing s.r.o. at 1 site in Slovakia.
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 10 inclusion and 11 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 5 Jun 2024. 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 Slovakia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Non-healing wounds measuring (time frame: 6 + 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.