Effect of Mesenchymal Stem Cells on Healing of Foot Ulcers in Diabetes Patients.

Inclusion Criteria:

• Diagnosis of diabetes mellitus for at least 3 months.
• Age 40-75 years.
• A foot ulcer below the level of the malleoli, excluding ulcers confined to the digitsor interdigital cleft. If more than one ulcer, the largest will be selected atscreening as the index ulcer.
• Wound area after sharp debridement of ≥ 50 mm^2, but ≤1000 mm^2.

Exclusion Criteria:

• Signs of infection of the index ulcer.
• An ulcer where a probe investigation indicates ulcer depth to the underlying bone.
• Wound caused primarily by untreated vascular insufficiency, or where participants areprimarily eligible for vascular intervention to promote wound healing.
• Wounds with an etiology not related to diabetes.
• Underlying osteomyelitis of the leg with the wound to be treated.
• Participants presenting with the clinical characteristics of cellulitis at the woundsite (suppurative inflammation involving particularly the subcutaneous tissue, oftenmild erythema, tenderness, malaise, chills and fever).
• Surgery to lengthen achilles tendon on the leg with the wound to be treated 3 monthsprioer to signing the informed consent form.
• Necrosis, purulence, or sinus tracts that cannon be removed by debridement on foot tobe treated.
• Toe blood pressure < 44 mmHg at the foot with the index ulcer.
• Dialysis or an estimated glomerular filtration rate (GFR) (based on serum creatinine) < 20 ml/min/1.73 m^2.
• Current treatment with cytotoxic drugs.
• Hospitalisation for a major cardiovascular event or procedure or revascularizationsurgery on a leg in the last 3 months or scheduled major cardiovascular intervention.
• Abuse of alcohol or drugs, or presence of any condition that in the Investigatorsopinion may lead to poor adherence to study protocol.
• Recent use (< 3 months) of an investigational drug or participation in interventionalclinical foot ulcer-healing trial.
• Females capable of becoming pregnant must have a negative pregnancy test prior totransplantation. After inclusion, they must use contraceptives for 12 weeks followingthe given stem cell treatment. The pill, spirak, depot injection of progesterone,sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safecontraceptives.
• Likely inability yo comply with the need for clinical visits because of plannedactivity.
• Mental incapacity, unwillingness, or language barrier precluding adequateunderstanding or cooperation.
• Unable to provide written and signed informed consent.
• Any clinically significant disease or disorder, except for conditions associated tothe type 1 or 2 diabetes, which in the Investigator's opinion could interfere with theresults of the trial.
• Active cancer or a history of cancer in the 5 years prior to signing the informedconsent form (history of basal cell carcinoma is allowed).
• Life expectancy of less than 12 months.