AMNIODERM+ Medical Device Clinical Study

NCT06442865 | Completed

• 1 other identifier: AD+29082022ZP
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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+®.

Conditions

Non-healing Wound; Diabetic Foot

Keywords

medical device; AMNIODERM+; non-healing wounds; DFU

Outcome Measures

Primary Outcomes (1)

• 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.

  6 + 12 weeks

Study Arms (2)

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.

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+®.

Device: AMNIODERM+

Interventions

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.

Prospective data; Retrospective data

Eligibility Criteria

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

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.

You may qualify if:

• 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)
• 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
• 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

You may not qualify if:

• Necrotic wound requiring surgical treatment
• Pregnancy or breastfeeding
• Venous etiology of ulceration
• Burns or chemical burns
• Clinical manifestations of systemic infection
• Undermined wound edges
• 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

Sponsors & Collaborators

• BioHealing s.r.o.: lead

Study Sites (1)

Národní Endokrinologický a Diabetologický ústav

Ľubochňa, Slovakia

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 4, 2024
• Study Start: November 16, 2022
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

SL (1)