Diabetic Foot Ulcer Clinical Trial
— OdinnOfficial title:
An Open Label, Randomized Controlled Study to Compare Healing of Severe Diabetic Foot Ulcers and Forefoot Amputations in Diabetics With and Without Moderate Peripheral Arterial Disease Treated With Kerecis Omega3 Wound and SOC vs. SOC Alone
NCT number | NCT04257370 |
Other study ID # | KS-0370 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 9, 2020 |
Est. completion date | November 25, 2022 |
Verified date | February 2023 |
Source | Kerecis Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.
Status | Completed |
Enrollment | 260 |
Est. completion date | November 25, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diabetic patient with chronic lower extremity wounds: Grade 2 or 3 according to University of Texas score: Grade 2: "Wounds that penetrate to tendon or capsule". Grade 3: "wounds that penetrate to bone or into the joint". In this context, probing gently to bone means that the wound reaches bone. - OR patients with diabetes that are recently amputated below the ankle, where the wound has not been closed or has dehisced and bones/tendons are exposed. - Patients that have moderately decreased or normal arterial circulation. In this study the cutoff point is Ankle Brachial Index (ABP) below 0.6. (Toe pressure and TPCO2 values will be obtained if possible. Toe pressure of 50mmHg and a TCPO2 value of 40mm on the dorsum of the foot is often considered as indicative of adequate perfusion.) - Patients who will tolerate aggressive debridement. Light bleeding of the wound surface should be seen after debridement. - Patient has had his/her ulcer for one month. - Participant is willing and able to give informed consent for participation in the clinical trial. - Male or Female, over 18 years. - Geographical distance compatible with taking part in the study. Observe though that the patient can be treated at a "home clinic" every other week as long as the end point is not imminent and photos and acetate tracers with cm markers are fed into the photo portal. - Negative pregnancy test for a woman of childbearing age. - Patient is able (in the investigator's opinion) and willing to comply with all the clinical trial requirements. Exclusion Criteria: - Patient whose wound surface is not measurable. - Patients suffering from unmanaged osteomyelitis. With adequate treatment the patient can be re-screened for the study. - Patient with severe ischemia (Ankle Brachial Index (ABI) <0.6). - Patient with necrotic wound who will not tolerate aggressive debridement. - Patient with immune deficiency or autoimmune disease. - Patients having done arterial reconstruction within one month. These patients can be re-screened later. - Patient on systemic corticosteroids or other treatments causing delayed wound healing. - Female participants who are pregnant, breast feeding or planning pregnancy during the course of the clinical trial. - Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the clinical trial, or may influence the result of the clinical trial, or the participant's ability to participate in the clinical trial. - Patient with known allergy to fish. - Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure. |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Sud Francilien | Évry | Corbeil-Essonnes Cedex |
Lead Sponsor | Collaborator |
---|---|
Kerecis Ltd. | Allderma Pharmaceuticals, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète, Endospin |
France,
Barshes NR, Sigireddi M, Wrobel JS, Mahankali A, Robbins JM, Kougias P, Armstrong DG. The system of care for the diabetic foot: objectives, outcomes, and opportunities. Diabet Foot Ankle. 2013 Oct 10;4. doi: 10.3402/dfa.v4i0.21847. — View Citation
Margolis DJ, Allen-Taylor L, Hoffstad O, Berlin JA. Diabetic neuropathic foot ulcers: predicting which ones will not heal. Am J Med. 2003 Dec 1;115(8):627-31. doi: 10.1016/j.amjmed.2003.06.006. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound healing at Week 16 | Percentage of patients with complete wound epithelialisation at 16 weeks as assessed from photographs by a blinded assessor | 16 weeks | |
Secondary | Ulcer grade | Change in grade of ulcer according to the University of Texas diabetic wound classification at each weekly visit | 16 weeks | |
Secondary | Change in quality of life | Change in quality of life as assessed by a Wound Quality of Life questionnaire at each weekly visit. The questionnaire contains 17 questions about the patients' wounds and patients will be asked to rate between five values (e.g. Does your wound hurt? Available answers: "not at all", "a little", "moderately", "quite a lot", and "very much"). | 16 weeks | |
Secondary | Change in pain | Pain will be assessed by a visual analogue scale (VAS) at each weekly visit. The VAS will range from 0-10, with 0 being no pain at all, and 10 being worst pain imaginable, and patients will be asked to self-evaluate the pain they experience. | 16 weeks | |
Secondary | Healing trajectory | Healing trajectories will be plotted via the change in wound surface area in cm2, vs original wound size, calculated at each weekly visit | 16 weeks | |
Secondary | Cost effectiveness | Better cost-effectiveness than standard of care as calculated by global cost of wound treatment of the two arms and projected costs for non-healed ulcers | 16 weeks | |
Secondary | Number of participants with fully healed ulcers at 20 weeks | The number of patients with wounds with complete epithelialisation at 20 weeks will be calculated for each arm (checkpoint only) | 20 weeks | |
Secondary | Number of participants with fully healed ulcers at 24 weeks | The number of patients with wounds with complete epithelialisation at 24 weeks will be calculated for each arm (checkpoint only) | 24 weeks | |
Secondary | Percentage of ulcers healed 50% or more at 12 weeks | The percentage of ulcers healed 50% or more at 12 weeks will be compared between groups. 50% healing indicates epithelialisation of 50% of the original wound area in cm2. | 12 weeks |
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