Phase
Condition
Diabetic Gastroparesis
Diabetes Mellitus, Type 2
Diabetic Neuropathy
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diabetic patients, regardless of the age of their diabetes, with a grade UT 2 or 3lower limb sore; grade 2: wound penetrating to the tendon or capsule. UT grade 3:wound penetrating to the bone or joint OR hospitalized/ambulatory patients fordiabetic foot sores or amputations, which have not closed or are dehiscent.
- Patients who can tolerate aggressive surgical debridement
- Patients without severe ischemia IPS - 0.6 or pressure of the big toe - 50mmHg
- Longness of the wound: 30 days (does not apply to amputation wounds; patients may beincluded when the wound is less than 30 days old) OR if the amputation level is underthe ankle
- Patients willing and able to give informed consent to participate in the clinicaltrial.
- Male or female over the age of 18
- Patients living at a geographical distance compatible with referral nurse visits
- Negative pregnancy test for women of childbearing age who do not use contraception.
- Patients covered by social security
- Patients who are capable (in the investigator's opinion) and willing to comply withall clinical trial requirements
Exclusion
Exclusion Criteria:
- Patients whose wound surface is not measurable
- Patients with unsealed osteomyelitis
- Patients with fever related to a foot infection (it may be reassessed at a later timewhen the infection is gone)
- Patients with a necrotic wound that will not tolerate aggressive surgical debridement
- Immunosuppressed patients
- Patients with systemic corticosteroids or other treatments that may delay woundhealing
- Pregnant, breast-feeding or planning pregnancy during the clinical trial
- Any other significant disease or disorder that the investigator believes may pose arisk to participants because of their participation in the clinical trial or that mayinfluence the outcome of the clinical trial or the participant's ability toparticipate in the clinical trial.
- Patients with rheumatoid arthritis
- Patients with systemic lupus
- Patients with a known skin allergy to fish
- Patients deprived of liberty by judicial or administrative decision, persons subjectto a legal protection measure
Study Design
Connect with a study center
CHU de Caen
Caen, 14033
FranceSite Not Available
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
FranceSite Not Available
CHU de Dijon - Bocage Sud
Dijon, 21000
FranceSite Not Available
Hotel Dieu Le Creusot
Le Creusot, 71200
FranceSite Not Available
CHU de Montpellier
Montpellier, 34295
FranceSite Not Available
Hopital Bichat-Claude Bernard
Paris, 75018
FranceSite Not Available
Hôpital Cochin
Paris, 75014
FranceSite Not Available
CHU de Reims - Hôpital Debré
Reims, 51100
FranceSite Not Available
Hôpital de Roubaix - CETRADIM
Roubaix, 59100
FranceSite Not Available
CHU de Nantes Hôpital Nord Laennec
Saint Herblain, 44093
FranceSite Not Available
CHRU de Strasbourg - Hopital Civil
Strasbourg, 67091
FranceSite Not Available
CHU de Toulouse Hôpital Rangueil
Toulouse, 31059
FranceSite Not Available

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