AMNIODERM+ Medical Device Clinical Study

BioHealing s.r.o.20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Non-healing Wound Diabetic Foot

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Males and females over 18 years of age 2. Type 1 or Type 2 diabetes mellitus 3. 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) 4. History of an evaluable defect ≥ 6 weeks and ≤ 104 weeks prior to clinical trial inclusion 5. Size of a wound to be evaluated 2 to 16 cm2 6. Wound treatment can be provided either on an inpatient or outpatient basis, based on the doctor's decision 7. The subject agrees to periodic visits to the clinical trial site during their participation in the clinical trial 8. The subject is able to understand the clinical trial information 9. Signed informed consent form 10. Data on previous wound care are available in the subject medical documentation Exclusion Criteria: 1. Necrotic wound requiring surgical treatment 2. Pregnancy or breastfeeding 3. Venous etiology of ulceration 4. Burns or chemical burns 5. Clinical manifestations of systemic infection 6. Undermined wound edges 7. The wound involves deeper structures (bone, tendons, joints) 8. Inadequately controlled diabetes mellitus with HbA1c \> 12 % (DCCT) diabetes mellitus 9. Renal insufficiency with eGF \< 30ml/min/1.73m2 10. Infected ulceration either Stage ≥2 according to EWMA Position Document (2006) (Appendix II) or with CRP \>10 11. Topical treatment with any growth factor-based products

Locations (1)

Národní Endokrinologický a Diabetologický ústav

Ľubochňa, Slovakia

Outcomes

Primary Outcomes

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.

Time frame: 6 + 12 weeks

Data from ClinicalTrials.gov

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