Skip to main content
OpenTrials
Completed

NCT Number: NCT03276312

Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot

This is a randomized controlled monocentric study on 114 diabetic patients with the aim of evaluating the efficacy of the lipofilling with Lipogems® system in diabetic patients that are candidates for a minor amputation in the foot. In particular, it will be evaluated whether the lipofilling will be able to shorten the healing times and to reduce the number of major amputations, with consequent positive impact on the quality of life. Patients will be randomized to the treatment group with Lipogems® (local injection of autologous micro-fractured adipose tissue) or to the control group, thus, treatment according to standard clinical practice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Modena and Reggio Emilia

Modena, 41100, Italy

About this study

Primary objective of this study is the evaluation of the time of the healing of the lesions resulting from minor amputations (digital or forefoot) treated with Lipogems® technique.

Secondary objectives are: 1) assessment of the safety of the lipofilling; 2) evaluation of the intensity of pain (VAS); 3) assessment of the skin tropism; 4) calculation of the relapse rate (defined as the occurrence of local infections, dehiscence and suffering of skin flaps that lead to a revision of the amputation stump or amputation at a higher level); 5) evaluation of the time of hospitalization and quality of life (QoL).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with diabetes (diabetes mellitus type 1 and type 2) of both sexes over the age of 18 years.
  • Presence of irreversible gangrene digital or localized at forefoot (with X-ray of the foot negative or positive for osteolytic lesions at phalanges and/or metatarsus).
  • Patients with vascular problems absent or resolved (evaluated with Eco Color Doppler and ABI (Ankle Brachial Index, that calculates the ratio of the systolic pressure measured at the ankle and the systolic pressure in the arm, both measured in supine position using wave continue Doppler. If assessable, it has to be greater than/equal to 0.7) and pressure index finger/arm TBI (Toe Brachial Index, if assessable, it has to be greater than/equal to 0.6) and/or by the determination of the transcutaneous oxygen pressure (TcPO2 that needs to be equal to or greater than 30mmHg).

Exclusion criteria

  • Oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
  • Patient under steroid therapy
  • Active vascular issues

Treatment and study plan

Lipogems

Device

Lipogems® is an innovative system that, starting from minimum quantities of autologous lipoaspirate, provides, with a minimal manipulation, a micro-fragmented and non-expanded adipose tissue product

Primary outcomes

  1. Healing time

    Time frame: 6 months

    Healing time after the minor amputation intended as the complete healing of the amputation stump

Secondary outcomes

  1. Safety: All types of adverse events will be collected

    Time frame: 6 months

    All types of adverse events will be collected

  2. Incidence of relapse

    Time frame: 6 months

    Relapse is intended as revision of the amputation stump or amputation at a higher level

  3. Pain assessed using the Visual Analogue Scale (VAS) for pain

    Time frame: 6 months

    Pain will be assessed using the VAS pain scale

  4. Total time of hospitalization

    Time frame: 6 months

    Hospitalization of the patient will be assessed counting the number of days in hospital

  5. Total time of immobility

    Time frame: 6 months

    Immobility of the patient will be assessed counting the number of bed rest days

  6. Quality of Life using the Short Form 36 (SF-36) questionnaire

    Time frame: 6 months

    Assessment of the quality of life (QoL) before surgery and during all the subsequent follow up visits using the SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

Local Inoculation of Autologous Micro-fragmented Adipose Tissue in the Treatment of Minor Amputations of Diabetic Foot: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 8, 2017
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.